(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 | |