| (NDA) 209935 | 001 | KISQALI FEMARA CO-PACK (COPACKAGED)P | LETROZOLE; RIBOCICLIB SUCCINATE | TABLET, TABLET;ORAL | 2.5MG,N/A;N/A,EQ 200MG BASE | NOVARTIS PHARMS CORP | 2017-05-04 | Yes | RX | |
| (NDA) 209862 | 001 | EVZIOP | NALOXONE HYDROCHLORIDE | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 2MG/0.4ML (2MG/0.4ML) | KALEO INC | 2016-10-19 | Yes | RX | |
| (NDA) 209777 | 001 | ROXYBONDP | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 5MG | INSPIRION DELIVERY | 2017-04-20 | No | RX | |
| (NDA) 209777 | 002 | ROXYBONDP | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 15MG | INSPIRION DELIVERY | 2017-04-20 | No | RX | |
| (NDA) 209777 | 003 | ROXYBONDP | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 30MG | INSPIRION DELIVERY | 2017-04-20 | No | RX | |
| (NDA) 209661 | 001 | BONJESTAP | DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 20MG;20MG | DUCHESNAY | 2016-11-07 | Yes | RX | |
| (NDA) 209531 | 001 | SPINRAZAP | NUSINERSEN SODIUM | SOLUTION;INTRATHECAL | 12MG/5ML (2.4MG/ML) | BIOGEN IDEC | 2016-12-23 | Yes | RX | |
| (NDA) 209512 | 001 | NORVIR | RITONAVIR | POWDER;ORAL | 100MG/PACKET | ABBVIE INC | 2017-06-07 | Yes | RX | |
| (NDA) 209463 | 001 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | POWDER;IV (INFUSION) | EQ 40MG BASE/VIAL | EXELA PHARMA SCS LLC | 2017-06-30 | No | RX | |
| (NDA) 209387 | 001 | NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | SODIUM NITROPRUSSIDE | SOLUTION;IV (INFUSION) | 50MG/100ML (0.5MG/ML) | EXELA PHARMA SCS LLC | 2017-03-08 | Yes | RX | |
| (NDA) 209347 | 001 | GANCICLOVIRP | GANCICLOVIR | SOLUTION;IV (INFUSION) | 500MG/250ML (2MG/ML) | EXELA PHARMA SCS LLC | 2017-02-17 | Yes | RX | |
| (ANDA) 209336 | 001 | FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | OIL;TOPICAL | 0.01% | TARO | 2016-05-19 | No | RX | AT |
| (NDA) 209269 | 001 | MINOLIRA | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 105MG BASE | DR REDDYS LABS LTD | 2017-05-08 | No | RX | |
| (NDA) 209269 | 002 | MINOLIRA | MINOCYCLINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 135MG BASE | DR REDDYS LABS LTD | 2017-05-08 | No | RX | |
| (NDA) 209241 | 001 | INGREZZAP | VALBENAZINE TOSYLATE | CAPSULE;ORAL | 40MG | NEUROCRINE | 2017-04-11 | Yes | RX | |
| (ANDA) 209221 | 001 | AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | CAPSULE;ORAL | 100MG | LANNETT HOLDINGS INC | 2017-06-15 | No | RX | AB |
| (ANDA) 209207 | 001 | IBUPROFEN | IBUPROFEN | SUSPENSION;ORAL | 100MG/5ML | TARO | 2017-06-27 | No | OTC | |
| (ANDA) 209204 | 001 | IBUPROFEN | IBUPROFEN | SUSPENSION;ORAL | 100MG/5ML | TARO | 2017-06-23 | No | RX | AB |
| (ANDA) 209177 | 001 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 12.5MG | STRIDES PHARMA | 2017-06-30 | No | RX | AB |
| (ANDA) 209177 | 002 | PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | STRIDES PHARMA | 2017-06-30 | No | RX | AB |
