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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) 216331 001 ACYCLOVIR ACYCLOVIR SUSPENSION;ORAL 200MG/5ML AUROBINDO PHARMA LTD 2022-03-31 No RX AB
(ANDA) 216250 001 LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE SOLUTION;TOPICAL 4% NOVITIUM PHARMA 2022-03-23 No RX AT
(ANDA) 216244 001 ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML EUGIA PHARMA 2022-03-21 No RX AP
(ANDA) 216244 002 ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 20MG/ML EUGIA PHARMA 2022-03-21 No RX AP
(ANDA) 216232 001 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE MICRO LABS 2022-03-29 No RX AB1
(ANDA) 216232 002 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE MICRO LABS 2022-03-29 No RX AB1
(ANDA) 216232 003 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE MICRO LABS 2022-03-29 No RX AB
(ANDA) 216211 001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE TABLET;ORAL 25MG;37.5MG RUBICON 2022-02-23 No RX AB
(ANDA) 216211 002 TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE TABLET;ORAL 50MG;75MG RUBICON 2022-02-23 No RX AB
(NDA) 216196 001 PYRUKYNDP MITAPIVAT SULFATE TABLET;ORAL EQ 5MG BASE AGIOS PHARMS INC 2022-02-17 Yes RX
(NDA) 216196 002 PYRUKYNDP MITAPIVAT SULFATE TABLET;ORAL EQ 20MG BASE AGIOS PHARMS INC 2022-02-17 Yes RX
(NDA) 216196 003 PYRUKYNDP MITAPIVAT SULFATE TABLET;ORAL EQ 50MG BASE AGIOS PHARMS INC 2022-02-17 Yes RX
(NDA) 216157 001 OXBRYTAP VOXELOTOR TABLET, FOR SUSPENSION;ORAL 300MG GLOBAL BLOOD THERAPS 2021-12-17 Yes RX
(ANDA) 216146 001 EPHEDRINE SULFATE EPHEDRINE SULFATE SOLUTION;INTRAVENOUS 50MG/ML (50MG/ML) GLAND PHARMA LTD 2022-02-25 No RX AP
(ANDA) 216067 001 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE;ORAL 30MG ALKEM LABS LTD 2022-03-29 No RX AB2
(ANDA) 216067 002 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE;ORAL 60MG ALKEM LABS LTD 2022-03-29 No RX AB2
(ANDA) 216067 003 NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE;ORAL 90MG ALKEM LABS LTD 2022-03-29 No RX AB2
(ANDA) 216030 001 FAMOTIDINE FAMOTIDINE TABLET;ORAL 10MG ASCENT PHARMS INC 2021-11-03 No OTC
(ANDA) 216030 002 FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG ASCENT PHARMS INC 2021-11-03 No OTC
(NDA) 216018 001 ASPRUZYO SPRINKLE RANOLAZINE GRANULES, EXTENDED RELEASE;ORAL 500MG SPIL 2022-02-28 Yes RX