Medication Guide - 7/1/2022

Medication guides are FDA- approved documents that address issues that are specific to particular drugs, and can help patients avoid serious adverse events (side effects). This database does not include Medication Guides for FDA-approved allergenic or cellular/tissue products (see  FDA Online Label Repository  or DailyMed  for these Medication Guides).  More Drug Name Active Ingredient Form;Route Appl. No. Company Date Drug Name Active Ingredient Form;Route Appl. No. Company Date Qsymia Phentermine Hydrochloride; Topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580 VIVUS 06/24/2022 Tafinlar Dabrafenib Mesylate CAPSULE;ORAL 202806 NOVARTIS 06/22/2022 Steglujan Ertugliflozin; Sitagliptin Phosphate TABLET;ORAL 209805 MERCK SHARP DOHME 06/21/2022 Mayzent Siponimod Fumaric Acid TABLET;ORAL 209884 NOVARTIS 06/21/2022 Januvia Sitagliptin Phosphate TABLET;ORAL 021995 MERCK SHARP DOHME 06/21/2022 Janumet XR Metformin Hydrochloride; Sitagliptin Phosphate TABLET, EXTENDED RELEASE;ORAL 202270 MERCK SHARP DOHME 06/21/2022 Janumet Metformin Hydrochloride; Sitagliptin Phosphate TABLET;ORAL 022044 MERCK SHARP DOHME 06/21/2022 Zubsolv Buprenorphine Hydrochloride; Naloxone Hydrochloride TABLET;SUBLINGUAL 204242 OREXO US INC 06/17/2022 Tegsedi Inotersen Sodium SOLUTION;SUBCUTANEOUS 211172 AKCEA THERAPS 06/17/2022 Subutex Buprenorphine Hydrochloride TABLET;SUBLINGUAL 020732 INDIVIOR INC 06/17/2022 Suboxone Buprenorphine Hydrochloride; Naloxone Hydrochloride TABLET;SUBLINGUAL 020733 INDIVIOR INC 06/17/2022 Suboxone Buprenorphine Hydrochloride; Naloxone Hydrochloride FILM;BUCCAL, SUBLINGUAL 022410 INDIVIOR INC 06/17/2022 Probuphine Buprenorphine Hydrochloride IMPLANT;IMPLANTATION 204442 TITAN PHARMS 06/17/2022 Hadlima Adalimumab-Bwwd INJECTABLE;INJECTION 761059 SAMSUNG BIOEPIS CO LTD 06/17/2022 Cassipa Buprenorphine Hydrochloride; Naloxone Hydrochloride FILM;SUBLINGUAL 208042 TEVA PHARMS USA 06/17/2022 Butrans Buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306 PURDUE PHARMA LP 06/17/2022 Bunavail Buprenorphine Hydrochloride; Naloxone Hydrochloride FILM;BUCCAL 205637 BDSI 06/17/2022 Belbuca Buprenorphine Hydrochloride FILM;BUCCAL 207932 BDSI 06/17/2022 Zulresso Brexanolone SOLUTION;INTRAVENOUS 211371 SAGE THERAP 06/16/2022 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