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 | Caplyta | Lumateperone Tosylate | CAPSULE;ORAL | 209500 | INTRA-CELLULAR | 04/22/2022 | Fensolvi Kit | Leuprolide Acetate | POWDER;SUBCUTANEOUS | 213150 | TOLMAR | 04/22/2022 | Lupron Depot-Ped Kit | Leuprolide Acetate | POWDER;INTRAMUSCULAR | 020263 | ABBVIE ENDOCRINE INC | 04/22/2022 | Metadate CD | Methylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021259 | LANNETT CO INC | 04/22/2022 | Supprelin LA | Histrelin Acetate | IMPLANT;SUBCUTANEOUS | 022058 | ENDO PHARM | 04/22/2022 | Synarel | Nafarelin Acetate | SPRAY, METERED;NASAL | 019886 | PFIZER | 04/22/2022 | Triptodur Kit | Triptorelin Pamoate | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 208956 | ARBOR PHARMS LLC | 04/22/2022 | Jentadueto | Linagliptin; METformin Hydrochloride | TABLET;ORAL | 201281 | BOEHRINGER INGELHEIM | 04/15/2022 | Tradjenta | Linagliptin | TABLET;ORAL | 201280 | BOEHRINGER INGELHEIM | 04/15/2022 | Xigduo XR | Dapagliflozin; METformin Hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649 | ASTRAZENECA AB | 04/11/2022 | Ibsrela | Tenapanor Hydrochloride | TABLET;ORAL | 211801 | ARDELYX INC | 04/05/2022 | Solaraze | Diclofenac Sodium | GEL;TOPICAL | 021005 | FOUGERA PHARMS | 04/05/2022 |
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