Medication Guide - 6/28/2021

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 Focalin Dexmethylphenidate Hydrochloride TABLET;ORAL 021278 NOVARTIS 06/26/2021 Focalin XR Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802 NOVARTIS 06/26/2021 Ritalin Methylphenidate Hydrochloride TABLET;ORAL 010187 NOVARTIS 06/26/2021 Ritalin LA Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284 NOVARTIS 06/26/2021 Adhansia XR Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212038 PURDUE PHARMA LP 06/25/2021 Concerta Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121 JANSSEN PHARMS 06/25/2021 Cotempla XR-Odt Methylphenidate TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 205489 NEOS THERAPS INC 06/25/2021 Daytrana Methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514 NOVEN PHARMS INC 06/25/2021 Jornay PM Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 209311 IRONSHORE PHARMS 06/25/2021 Metadate CD Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021259 LANNETT CO INC 06/25/2021 Methylin Methylphenidate Hydrochloride SOLUTION;ORAL 021419 SPECGX LLC 06/25/2021 Methylin Methylphenidate Hydrochloride TABLET, CHEWABLE;ORAL 021475 SPECGX LLC 06/25/2021 Quillichew ER Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960 NEXTWAVE PHARMS 06/25/2021 Quillivant XR Methylphenidate Hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100 NEXTWAVE 06/25/2021 Austedo Deutetrabenazine TABLET;ORAL 208082 TEVA BRANDED PHARM 06/24/2021 Pradaxa Dabigatran Etexilate Mesylate CAPSULE;ORAL 022512 BOEHRINGER INGELHEIM 06/21/2021 Pradaxa Dabigatran PELLETS;ORAL 214358 BOEHRINGER INGELHEIM 06/21/2021 Byetta Exenatide Synthetic INJECTABLE;SUBCUTANEOUS 021773 ASTRAZENECA AB 06/17/2021 Inflectra Infliximab-Dyyb INJECTABLE;INJECTION 125544 CELLTRION INC 06/17/2021 Sublocade Buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819 INDIVIOR INC 06/17/2021 Glyxambi Empagliflozin; Linagliptin TABLET;ORAL 206073 BOEHRINGER INGELHEIM 06/11/2021 Jardiance Empagliflozin TABLET;ORAL 204629 BOEHRINGER INGELHEIM 06/11/2021 Synjardy Empagliflozin; METformin Hydrochloride TABLET;ORAL 206111 BOEHRINGER INGELHEIM 06/11/2021 Synjardy XR Empagliflozin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 208658 BOEHRINGER INGELHEIM 06/11/2021 Trijardy XR Empagliflozin; Linagliptin; METformin Hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614 BOEHRINGER INGELHEIM 06/11/2021 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