CDER New: 4/30/2021

What's New Related to Drugs Updated Monday through Friday: Drug Firm Annual Registration Status Drug Firm Annual Registration Status Download File National Drug Code Directory NDC Unfinished Drugs Excluded Database File NDC Database Excluded Packages and Products Wholesale Distributor and Third-Party Logistics Providers Reporting April 29, 2021 Drug Safety Oversight Board (DSOB) Meeting March 31, 2021, Public Summary FDA Drug Shortages Amoxapine Tablets (Updated - Currently in Shortage) Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage) Azacitidine for Injection (Updated - Currently in Shortage) Cisatracurium Besylate Injection (Updated - Currently in Shortage) Fluvoxamine ER Capsules (Updated - Currently in Shortage) Recent New and Generic Drug Approvals This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA. April 29, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Metro I.V. In Plastic Container NDA #018900 Metronidazole Injectable; Injection SUPPL-38 B Braun Labeling Approved Zofran NDA #020007 Ondansetron Hydrochloride Injectable; Injection SUPPL-48 Novartis Labeling Approved Zofran Preservative Free NDA #020007 Ondansetron Hydrochloride Injectable; Injection SUPPL-48 Novartis Labeling Approved Zofran NDA #020103 Ondansetron Hydrochloride Tablet; Oral SUPPL-37 Novartis Labeling Approved Zofran NDA #020605 Ondansetron Hydrochloride Solution; Oral SUPPL-21 Novartis Labeling Approved Zofran Odt NDA #020781 Ondansetron Tablet, Orally Disintegrating; Oral SUPPL-21 Novartis Labeling Approved April 28, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Percodan NDA #007337 Aspirin; Oxycodone Hydrochloride Tablet; Oral SUPPL-53 Endo Pharms Labeling Approved Percodan NDA #007337 Aspirin; Oxycodone Hydrochloride Tablet; Oral SUPPL-53 Endo Pharms Labeling Approved Percodan NDA #007337 Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-53 Endo Pharms Labeling Approved Percodan NDA #007337 Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-53 Endo Pharms Labeling Approved Percodan-Demi NDA #007337 Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-53 Endo Pharms Labeling Approved Percodan-Demi NDA #007337 Aspirin; Oxycodone Hydrochloride; Oxycodone Terephthalate Tablet; Oral SUPPL-53 Endo Pharms Labeling Approved Synalgos-Dc NDA #011483 Aspirin; Caffeine; Dihydrocodeine Bitartrate Capsule; Oral SUPPL-34 Sun Pharm Industries Labeling Approved Synalgos-Dc NDA #011483 Aspirin; Caffeine; Dihydrocodeine Bitartrate Capsule; Oral SUPPL-34 Sun Pharm Industries Labeling Approved Equagesic NDA #011702 Aspirin; Meprobamate Tablet; Oral SUPPL-40 Sun Pharm Industries Labeling Approved Norgesic NDA #013416 Aspirin; Caffeine; Orphenadrine Citrate Tablet; Oral SUPPL-30 Medicis Labeling Approved Norgesic Forte NDA #013416 Aspirin; Caffeine; Orphenadrine Citrate Tablet; Oral SUPPL-30 Medicis Labeling Approved Ponstel NDA #015034 Mefenamic Acid Capsule; Oral SUPPL-45 Avion Pharms Labeling Approved Indocin NDA #016059 Indomethacin Capsule; Oral SUPPL-101 Egalet Labeling Approved Fiorinal NDA #017534 Aspirin; Butalbital; Caffeine Capsule; Oral SUPPL-74 Allergan Labeling Approved Fiorinal NDA #017534 Aspirin; Butalbital; Caffeine Tablet; Oral SUPPL-74 Allergan Labeling Approved Naprosyn NDA #017581 Naproxen Tablet; Oral SUPPL-115 Atnahs Pharma Us Labeling Approved Nalfon NDA #017604 Fenoprofen Calcium Capsule; Oral SUPPL-51 Xspire Pharma Labeling Approved Nalfon NDA #017604 Fenoprofen Calcium Capsule; Oral SUPPL-51 Xspire Pharma Labeling Approved Indocin NDA #017814 Indomethacin Suppository; Rectal SUPPL-44 Egalet Labeling Approved Feldene NDA #018147 Piroxicam Capsule; Oral SUPPL-50 Pfizer Labeling Approved Anaprox NDA #018164 Naproxen Sodium Tablet; Oral SUPPL-65 Atnahs Pharma Us Labeling Approved Anaprox Ds NDA #018164 Naproxen Sodium Tablet; Oral SUPPL-65 Atnahs Pharma Us Labeling Approved Indocin Sr NDA #018185 Indomethacin Capsule, Extended Release; Oral SUPPL-58 Egalet Labeling Approved Indocin NDA #018332 Indomethacin Suspension; Oral SUPPL-42 Egalet Labeling Approved Indomethacin NDA #018829 Indomethacin Capsule; Oral SUPPL-23 Chartwell Molecules Labeling Approved Indomethacin NDA #018829 Indomethacin Capsule; Oral SUPPL-23 Chartwell Molecules Labeling Approved Daypro NDA #018841 Oxaprozin Tablet; Oral SUPPL-33 Pfizer Labeling Approved Indomethacin NDA #018851 Indomethacin Capsule; Oral SUPPL-28 Heritage Labeling Approved Indomethacin NDA #018851 Indomethacin Capsule; Oral SUPPL-28 Heritage Labeling Approved Indomethacin NDA #018858 Indomethacin Capsule; Oral SUPPL-47 Mylan Labeling Approved Naprosyn NDA #018965 Naproxen Suspension; Oral SUPPL-27 Atnahs Pharma Us Labeling Approved Voltaren NDA #019201 Diclofenac Sodium Tablet, Delayed Release; Oral SUPPL-48 Novartis Labeling Approved Fiorinal W/Codeine NDA #019429 Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-44 Allergan Labeling Approved Fiorinal W/Codeine NDA #019429 Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral SUPPL-45 Allergan Labeling Approved Ec-Naprosyn NDA #020067 Naproxen Tablet, Delayed Release; Oral SUPPL-24 Atnahs Pharma Us Labeling Approved Cataflam NDA #020142 Diclofenac Potassium Tablet; Oral SUPPL-29 Novartis Labeling Approved Voltaren-Xr NDA #020254 Diclofenac Sodium Tablet, Extended Release; Oral SUPPL-30 Novartis Labeling Approved Naprelan NDA #020353 Naproxen Sodium Tablet, Extended Release; Oral SUPPL-38 Almatica Labeling Approved Naprelan NDA #020353 Naproxen Sodium Tablet, Extended Release; Oral SUPPL-38 Almatica Labeling Approved Arthrotec NDA #020607 Diclofenac Sodium; Misoprostol Tablet, Delayed Release; Oral SUPPL-38 Pfizer Labeling Approved Daypro Alta NDA #020776 Oxaprozin Potassium Tablet; Oral SUPPL-10 Pfizer Labeling Approved Mobic NDA #020938 Meloxicam Tablet; Oral SUPPL-28 Boehringer Ingelheim Labeling Approved Celebrex NDA #020998 Celecoxib Capsule; Oral SUPPL-56 Upjohn Labeling Approved Celebrex NDA #020998 Celecoxib Capsule; Oral SUPPL-56 Upjohn Labeling Approved Solaraze NDA #021005 Diclofenac Sodium Gel; Topical SUPPL-22 Fougera Pharms Labeling Approved Novolog Mix 70/30 BLA #021172 Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-74 Novo Nordisk Inc Labeling Approved Novolog Mix 70/30 BLA #021172 Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-74 Novo Nordisk Inc Labeling Approved Novolog Mix 70/30 Flexpen BLA #021172 Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-74 Novo Nordisk Inc Labeling Approved Novolog Mix 70/30 Flexpen BLA #021172 Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-74 Novo Nordisk Inc Labeling Approved Novolog Mix 70/30 Penfill BLA #021172 Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-74 Novo Nordisk Inc Labeling Approved Novolog Mix 70/30 Penfill BLA #021172 Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-74 Novo Nordisk Inc Labeling Approved Flector NDA #021234 Diclofenac Epolamine System; Topical SUPPL-19 Inst Biochem Labeling Approved Mobic NDA #021530 Meloxicam Suspension; Oral SUPPL-17 Avondale Pharms Labeling Approved Treximet NDA #021926 Naproxen Sodium; Sumatriptan Succinate Tablet; Oral SUPPL-18 Currax Labeling Approved Treximet NDA #021926 Naproxen Sodium; Sumatriptan Succinate Tablet; Oral SUPPL-17 Currax Labeling Approved Treximet NDA #021926 Naproxen Sodium; Sumatriptan Succinate Tablet; Oral SUPPL-18 Currax Labeling Approved Cambia NDA #022165 Diclofenac Potassium For Solution; Oral SUPPL-13 Assertio Labeling Approved Cambia NDA #022165 Diclofenac Potassium For Solution; Oral SUPPL-14 Assertio Labeling Approved Zyprexa Relprevv NDA #022173 Olanzapine Pamoate Suspension, Extended Release; Intramuscular SUPPL-39 Eli Lilly Co REMS Approved Caldolor NDA #022348 Ibuprofen Solution; Intravenous SUPPL-18 Cumberland Pharms Labeling Approved Sprix NDA #022382 Ketorolac Tromethamine Spray, Metered; Nasal SUPPL-21 Zyla Labeling Approved Natroba NDA #022408 Spinosad Suspension; Topical SUPPL-10 Parapro Llc Efficacy Approved Vimovo NDA #022511 Esomeprazole Magnesium; Naproxen Tablet, Delayed Release; Oral SUPPL-26 Horizon Labeling Approved Duexis NDA #022519 Famotidine; Ibuprofen Tablet; Oral SUPPL-13 Horizon Labeling Approved Duexis NDA #022519 Famotidine; Ibuprofen Tablet; Oral SUPPL-13 Horizon Labeling Approved Carisoprodol and Aspirin ANDA #040116 Aspirin; Carisoprodol Tablet; Oral SUPPL-14 Sandoz Labeling Approved Carisoprodol, Aspirin and Codeine Phosphate ANDA #040118 Aspirin; Carisoprodol; Codeine Phosphate Tablet; Oral SUPPL-21 Sandoz Labeling Approved Carisoprodol, Aspirin and Codeine Phosphate ANDA #040118 Aspirin; Carisoprodol; Codeine Phosphate Tablet; Oral SUPPL-21 Sandoz Labeling Approved Ibuprofen ANDA #071268 Ibuprofen Tablet; Oral SUPPL-16 Contract Pharmacal Labeling Approved Ibuprofen ANDA #071268 Ibuprofen Tablet; Oral SUPPL-16 Contract Pharmacal Labeling Approved Ibuprofen ANDA #074978 Ibuprofen Suspension; Oral SUPPL-49 Actavis Mid Atlantic Labeling Approved Ibuprofen ANDA #074978 Ibuprofen Suspension; Oral SUPPL-49 Actavis Mid Atlantic Labeling Approved Diclofenac Sodium ANDA #074986 Diclofenac Sodium Tablet, Delayed Release; Oral SUPPL-3 Micro Labs Labeling Approved Orphenadrine Citrate, Aspirin, and Caffeine ANDA #074988 Aspirin; Caffeine; Orphenadrine Citrate Tablet; Oral SUPPL-1 Stevens J Labeling Approved Etodolac ANDA #075009 Etodolac Tablet; Oral SUPPL-21 Teva Labeling Approved Etodolac ANDA #075009 Etodolac Tablet; Oral SUPPL-21 Teva Labeling Approved Orphengesic ANDA #075141 Aspirin; Caffeine; Orphenadrine Citrate Tablet; Oral SUPPL-2 Galt Pharms Labeling Approved Orphengesic Forte ANDA #075141 Aspirin; Caffeine; Orphenadrine Citrate Tablet; Oral SUPPL-2 Galt Pharms Labeling Approved Nabumetone ANDA #075189 Nabumetone Tablet; Oral SUPPL-31 Impax Labs Inc Labeling Approved Nabumetone ANDA #075189 Nabumetone Tablet; Oral SUPPL-31 Impax Labs Inc Labeling Approved Diclofenac Potassium ANDA #075229 Diclofenac Potassium Tablet; Oral SUPPL-23 Rubicon Labeling Approved Ketoprofen ANDA #075270 Ketoprofen Capsule, Extended Release; Oral SUPPL-14 Actavis Labs Fl Inc Labeling Approved Ketoprofen ANDA #075270 Ketoprofen Capsule, Extended Release; Oral SUPPL-14 Actavis Labs Fl Inc Labeling Approved Diclofenac Potassium ANDA #075463 Diclofenac Potassium Tablet; Oral SUPPL-18 Rk Pharma Labeling Approved Diclofenac Potassium ANDA #075463 Diclofenac Potassium Tablet; Oral SUPPL-18 Rk Pharma Labeling Approved Etodolac ANDA #075696 Etodolac Tablet, Extended Release; Oral SUPPL-16 Actavis Elizabeth Labeling Approved Etodolac ANDA #075696 Etodolac Tablet, Extended Release; Oral SUPPL-16 Actavis Elizabeth Labeling Approved Diclofenac Sodium ANDA #076201 Diclofenac Sodium Tablet, Extended Release; Oral SUPPL-27 Dexcel Ltd Labeling Approved Diclofenac Sodium ANDA #076201 Diclofenac Sodium Tablet, Extended Release; Oral SUPPL-27 Dexcel Ltd Labeling Approved Hydrocodone Bitartrate and Ibuprofen ANDA #076604 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-25 Actavis Labs Fl Inc Labeling Approved Hydrocodone Bitartrate and Ibuprofen ANDA #076604 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-25 Actavis Labs Fl Inc Labeling Approved Hydrocodone Bitartrate and Ibuprofen ANDA #076642 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-32 Amneal Pharms Ny Labeling Approved Hydrocodone Bitartrate and Ibuprofen ANDA #076642 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-32 Amneal Pharms Ny Labeling Approved Reprexain ANDA #076642 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-32 Amneal Pharms Ny Labeling Approved Reprexain ANDA #076642 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-32 Amneal Pharms Ny Labeling Approved Ibuprofen ANDA #076925 Ibuprofen Suspension; Oral SUPPL-47 L Perrigo Co Labeling Approved Ketorolac Tromethamine ANDA #078145 Ketorolac Tromethamine Injectable; Injection SUPPL-5 Luitpold Labeling Approved Ketorolac Tromethamine ANDA #078145 Ketorolac Tromethamine Injectable; Injection SUPPL-5 Luitpold Labeling Approved Oxycodone Hydrochloride and Ibuprofen ANDA #078316 Ibuprofen; Oxycodone Hydrochloride Tablet; Oral SUPPL-13 Barr Labs Inc Labeling Approved Oxycodone Hydrochloride and Ibuprofen ANDA #078316 Ibuprofen; Oxycodone Hydrochloride Tablet; Oral SUPPL-13 Barr Labs Inc Labeling Approved Ibuprofen ANDA #078329 Ibuprofen Tablet; Oral SUPPL-15 Strides Pharma Labeling Approved Nabumetone ANDA #078671 Nabumetone Tablet; Oral SUPPL-20 Invagen Pharms Labeling Approved Nabumetone ANDA #078671 Nabumetone Tablet; Oral SUPPL-20 Invagen Pharms Labeling Approved Ketorolac Tromethamine ANDA #078737 Ketorolac Tromethamine Injectable; Injection SUPPL-15 Sun Pharm Labeling Approved Oxycodone Hydrochloride and Ibuprofen ANDA #078769 Ibuprofen; Oxycodone Hydrochloride Tablet; Oral SUPPL-32 Actavis Elizabeth Labeling Approved Oxycodone Hydrochloride and Ibuprofen ANDA #078769 Ibuprofen; Oxycodone Hydrochloride Tablet; Oral SUPPL-32 Actavis Elizabeth Labeling Approved Nabumetone ANDA #090445 Nabumetone Tablet; Oral SUPPL-4 Annora Pharma Labeling Approved Ibuprofen ANDA #090796 Ibuprofen Tablet; Oral SUPPL-4 Marksans Pharma Labeling Approved Ibuprofen ANDA #091625 Ibuprofen Tablet; Oral SUPPL-14 Granules Labeling Approved Ibuprofen ANDA #091625 Ibuprofen Tablet; Oral SUPPL-14 Granules Labeling Approved Oxycodone and Aspirin ANDA #091670 Aspirin; Oxycodone Hydrochloride Tablet; Oral SUPPL-8 Mayne Pharma Inc Labeling Approved Campath BLA #103948 Alemtuzumab Vial; Intravenous SUPPL-5182 Genzyme Labeling Approved Campath BLA #103948 Alemtuzumab Vial; Intravenous SUPPL-5182 Genzyme Labeling Approved Lemtrada BLA #103948 Alemtuzumab Injectable; Injection SUPPL-5182 Genzyme Labeling Approved Lemtrada BLA #103948 Alemtuzumab Injectable; Injection SUPPL-5182 Genzyme Labeling Approved Morphine Sulfate NDA #202515 Morphine Sulfate Injectable; Injection SUPPL-25 Hospira Inc Labeling Approved Nabumetone ANDA #203166 Nabumetone Tablet; Oral SUPPL-3 Lgm Pharma Labeling Approved Injectafer NDA #203565 Ferric Carboxymaltose Solution; Intravenous SUPPL-14 Am Regent Efficacy Approved Ibuprofen ANDA #204062 Ibuprofen Tablet; Oral SUPPL-3 Hec Pharm Labeling Approved Ibuprofen ANDA #204062 Ibuprofen Tablet; Oral SUPPL-3 Hec Pharm Labeling Approved Diclofenac Sodium ANDA #204132 Diclofenac Sodium Solution; Topical SUPPL-6 Lupin Ltd Labeling Approved Diclofenac Sodium ANDA #204132 Diclofenac Sodium Solution; Topical SUPPL-6 Lupin Ltd Labeling Approved Ketorolac Tromethamine ANDA #204216 Ketorolac Tromethamine Injectable; Injection SUPPL-10 Gland Pharma Ltd Labeling Approved Hydrocodone Bitartrate and Ibuprofen ANDA #204575 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-7 Aurolife Pharma Llc Labeling Approved Hydrocodone Bitartrate and Ibuprofen ANDA #204575 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral SUPPL-7 Aurolife Pharma Llc Labeling Approved Zorvolex NDA #204592 Diclofenac Capsule; Oral SUPPL-13 Zyla Labeling Approved Pennsaid NDA #204623 Diclofenac Sodium Solution; Topical SUPPL-11 Horizon Labeling Approved Tivorbex NDA #204768 Indomethacin Capsule; Oral SUPPL-8 Genus Labeling Approved Tivorbex NDA #204768 Indomethacin Capsule; Oral SUPPL-8 Genus Labeling Approved Indomethacin ANDA #204853 Indomethacin Capsule, Extended Release; Oral SUPPL-2 Novast Labs Labeling Approved Indomethacin ANDA #204853 Indomethacin Capsule, Extended Release; Oral SUPPL-2 Novast Labs Labeling Approved Yosprala NDA #205103 Aspirin; Omeprazole Tablet, Delayed Release; Oral SUPPL-7 Genus Lifesciences Labeling Approved Yosprala NDA #205103 Aspirin; Omeprazole Tablet, Delayed Release; Oral SUPPL-7 Genus Lifesciences Labeling Approved Ibuprofen ANDA #205647 Ibuprofen Suspension; Oral SUPPL-8 Akorn Labeling Approved Ibuprofen ANDA #205647 Ibuprofen Suspension; Oral SUPPL-8 Akorn Labeling Approved Diclofenac Sodium ANDA #205878 Diclofenac Sodium Solution; Topical SUPPL-2 Novel Labs Inc Labeling Approved Licart NDA #206976 Diclofenac Epolamine System; Topical SUPPL-7 Ibsa Inst Bio Labeling Approved Vivlodex NDA #207233 Meloxicam Capsule; Oral SUPPL-4 Zyla Labeling Approved Etodolac ANDA #208834 Etodolac Tablet; Oral SUPPL-5 Amneal Pharms Co Labeling Approved Etodolac ANDA #208834 Etodolac Tablet; Oral SUPPL-5 Amneal Pharms Co Labeling Approved Etodolac ANDA #209888 Etodolac Tablet; Oral SUPPL-2 Edenbridge Pharms Labeling Approved Consensi NDA #210045 Amlodipine Besylate; Celecoxib Tablet; Oral SUPPL-9 Coeptis Labeling Approved Anjeso NDA #210583 Meloxicam Solution; Intravenous SUPPL-1 Baudax Labeling Approved Ketorolac Tromethamine ANDA #210616 Ketorolac Tromethamine Tablet; Oral SUPPL-1 Cycle Pharms Ltd Labeling Approved Ketorolac Tromethamine ANDA #210616 Ketorolac Tromethamine Tablet; Oral SUPPL-1 Cycle Pharms Ltd Labeling Approved Ketorolac Tromethamine ANDA #210616 Ketorolac Tromethamine Tablet; Oral SUPPL-1 Cycle Pharms Ltd Labeling Approved Qmiiz Odt NDA #211210 Meloxicam Tablet, Orally Disintegrating; Oral SUPPL-2 Tersera Labeling Approved Qmiiz Odt NDA #211210 Meloxicam Tablet, Orally Disintegrating; Oral SUPPL-2 Tersera Labeling Approved Sodium Chloride 14.6% ANDA #212070 Sodium Chloride Solution; Intravenous ORIG-1 Fresenius Kabi Usa   Approved Elyxyb NDA #212157 Celecoxib Solution; Oral SUPPL-2 Dr Reddys Labeling Approved Elyxyb NDA #212157 Celecoxib Solution; Oral SUPPL-2 Dr Reddys Labeling Approved Sodium Chloride 23.4% ANDA #212248 Sodium Chloride Injectable; Injection ORIG-1 Fresenius Kabi Usa   Approved Clindamycin Phosphate and Benzoyl Peroxide ANDA #212433 Benzoyl Peroxide; Clindamycin Phosphate Gel; Topical ORIG-1 Encube   Approved Droxidopa ANDA #213033 Droxidopa Capsule; Oral ORIG-1 Mylan Api   Approved Manage Subscriptions  |  Unsubscribe All  |  Help This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA