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Application No Product No Proprietary Name Active Ingredient Dosage Form;Route Strength Company Approval Date RLD Marketing Status TE Code
(ANDA) 217069 001 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) MANKIND PHARMA 2022-08-30 No RX AP1
(ANDA) 217069 002 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) MANKIND PHARMA 2022-08-30 No RX AP1
(ANDA) 217069 003 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) MANKIND PHARMA 2022-08-30 No RX AP1
(NDA) 217003 001 IMBRUVICA IBRUTINIB SUSPENSION;ORAL 70MG/ML PHARMACYCLICS INC 2022-08-24 Yes RX
(ANDA) 216651 001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE TABLET;ORAL 10MG HETERO LABS LTD III 2022-08-25 No RX AB
(ANDA) 216649 001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG APOTEX 2022-07-15 No RX AB
(ANDA) 216649 002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG APOTEX 2022-07-15 No RX AB
(ANDA) 216649 003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG APOTEX 2022-07-15 No RX AB
(ANDA) 216649 004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG APOTEX 2022-07-15 No RX AB
(ANDA) 216635 001 DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM FOR SOLUTION;ORAL 50MG ALKEM LABS LTD 2022-07-20 No RX AB
(ANDA) 216617 001 ACETAMINOPHEN ACETAMINOPHEN SOLUTION;INTRAVENOUS 1GM/100ML (10MG/ML) ASPIRO 2022-07-27 No RX AP
(ANDA) 216596 001 TIMOLOL MALEATE TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC EQ 0.5% BASE MICRO LABS 2022-09-07 No RX AT3
(ANDA) 216594 001 CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 100MG UMEDICA LABS PVT LTD 2022-08-18 No RX AB
(ANDA) 216594 002 CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 200MG UMEDICA LABS PVT LTD 2022-08-18 No RX AB
(ANDA) 216594 003 CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 400MG UMEDICA LABS PVT LTD 2022-08-18 No RX AB
(ANDA) 216591 001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 500MG BASE/VIAL ASPIRO 2022-07-06 No RX AP
(ANDA) 216591 002 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL ASPIRO 2022-07-06 No RX AP
(ANDA) 216531 001 AMBRISENTAN AMBRISENTAN TABLET;ORAL 5MG AUROBINDO PHARMA LTD 2022-07-21 No RX AB
(ANDA) 216531 002 AMBRISENTAN AMBRISENTAN TABLET;ORAL 10MG AUROBINDO PHARMA LTD 2022-07-21 No RX AB
(NDA) 216513 001 PHEBURANE SODIUM PHENYLBUTYRATE PELLETS;ORAL 84GM/BOT MEDUNIK 2022-06-17 Yes RX