• English
  • 简体中文
Login Register
Current Location: Home > Orange Book Search (FDA) Feedback Help
-
-
-
-
-
Export data
Application No Product No Proprietary Name Active Ingredient Dosage Form;Route Strength Company Approval Date RLD Marketing Status TE Code
(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