CDER New: 6/28/2021

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 June 25, 2021 Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (GREAT VI) Workshop on Eosinophilic Gastrointestinal Disorders Beyond EoE (update) - July 21, 2021 Over-The-Counter Monograph User Fee Program (OMUFA) (updated) Other OMUFA Fee-Related Questions (updated) Workshop: Safe Use of Benzodiazepines: Clinical, Regulatory, and Public Health Perspectives (new) - July 12-13, 2021 La FDA actualiza sobre los desinfectantes para manos que los consumidores no deben usar (update) Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies Guidance for Industry   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.   June 26, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Ritalin NDA #010187 Methylphenidate Hydrochloride Tablet; Oral SUPPL-93 Novartis Labeling Approved Focalin NDA #021278 Dexmethylphenidate Hydrochloride Tablet; Oral SUPPL-29 Novartis Labeling Approved Ritalin La NDA #021284 Methylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-43 Novartis Labeling Approved Focalin Xr NDA #021802 Dexmethylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-39 Novartis Labeling Approved June 25, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Rowasa NDA #019618 Mesalamine Enema; Rectal SUPPL-27 Mylan Speciality Lp Labeling Approved Sfrowasa NDA #019618 Mesalamine Enema; Rectal SUPPL-27 Mylan Speciality Lp Labeling Approved Dipentum NDA #019715 Olsalazine Sodium Capsule; Oral SUPPL-29 Mylan Speciality Lp Labeling Approved Concerta NDA #021121 Methylphenidate Hydrochloride Tablet, Extended Release; Oral SUPPL-44 Janssen Pharms Labeling Approved Metadate Cd NDA #021259 Methylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-32 Lannett Co Inc Labeling Approved Methylin NDA #021419 Methylphenidate Hydrochloride Solution; Oral SUPPL-20 Specgx Llc Labeling Approved Methylin NDA #021475 Methylphenidate Hydrochloride Tablet, Chewable; Oral SUPPL-11 Specgx Llc Labeling Approved Daytrana NDA #021514 Methylphenidate Film, Extended Release; Transdermal SUPPL-32 Noven Pharms Inc Labeling Approved Bridion NDA #022225 Sugammadex Sodium Solution; Intravenous SUPPL-8 Organon Sub Merck Efficacy Approved Sufentanil Citrate ANDA #074534 Sufentanil Citrate Injectable; Injection SUPPL-14 Hospira Labeling Approved Sufentanil Citrate ANDA #074534 Sufentanil Citrate Injectable; Injection SUPPL-15 Hospira Labeling Approved Metformin Hydrochloride ANDA #090295 Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-2 Marksans Pharma Labeling Approved Metformin Hydrochloride ANDA #090295 Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-3 Marksans Pharma Labeling Approved Temozolomide ANDA #201742 Temozolomide Capsule; Oral SUPPL-13 Sun Pharm Labeling Approved Temozolomide ANDA #201742 Temozolomide Capsule; Oral SUPPL-16 Sun Pharm Labeling Approved Temozolomide ANDA #201742 Temozolomide Capsule; Oral SUPPL-13 Sun Pharm Labeling Approved Temozolomide ANDA #201742 Temozolomide Capsule; Oral SUPPL-16 Sun Pharm Labeling Approved Quillivant Xr NDA #202100 Methylphenidate Hydrochloride For Suspension, Extended Release; Oral SUPPL-18 Nextwave Labeling Approved Ibuprofen ANDA #202413 Ibuprofen Tablet; Oral SUPPL-16 Shandong Xinhua Labeling Approved Ibuprofen ANDA #202413 Ibuprofen Tablet; Oral SUPPL-17 Shandong Xinhua Labeling Approved Metformin Hydrochloride ANDA #203832 Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-4 Nostrum Labs Inc Labeling Approved Metformin Hydrochloride ANDA #203832 Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-3 Nostrum Labs Inc Labeling Approved Metformin Hydrochloride ANDA #203832 Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-3 Nostrum Labs Inc Labeling Approved Decitabine ANDA #204607 Decitabine Injectable; Intravenous SUPPL-5 Pharmascience Inc Labeling Approved Cotempla Xr-Odt NDA #205489 Methylphenidate Tablet, Orally Disintegrating, Extended Release; Oral SUPPL-7 Neos Theraps Inc Labeling Approved Aptensio Xr NDA #205831 Methylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-6 Rhodes Pharms Labeling Approved Morphine Sulfate ANDA #207270 Morphine Sulfate Tablet; Oral ORIG-1 Mayne Pharma Inc   Tentative Approval Quillichew Er NDA #207960 Methylphenidate Hydrochloride Tablet, Extended Release, Chewable; Oral SUPPL-12 Nextwave Pharms Labeling Approved Jornay Pm NDA #209311 Methylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-8 Ironshore Pharms Labeling Approved Carospir NDA #209478 Spironolactone Suspension; Oral SUPPL-3 Cmp Dev Llc Labeling Approved Adhansia Xr NDA #212038 Methylphenidate Hydrochloride Capsule, Extended Release; Oral SUPPL-5 Purdue Pharma Lp Labeling 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