(NDA) 217639 | 001 | ORSERDU | ELACESTRANT DIHYDROCHLORIDE | 依拉司群 | TABLET;ORAL | EQ 86MG BASE | STEMLINE THERAP | 2023-01-27 | Yes | No | RX | |
(NDA) 217639 | 002 | ORSERDU | ELACESTRANT DIHYDROCHLORIDE | 依拉司群 | TABLET;ORAL | EQ 345MG BASE | STEMLINE THERAP | 2023-01-27 | Yes | Yes | RX | |
(NDA) 217415 | 001 | DAPTOMYCIN | DAPTOMYCIN | 达托霉素 | POWDER;INTRAVENOUS | 350MG/VIAL | XELLIA PHARMS APS | 2023-01-30 | Yes | Yes | RX | |
(NDA) 217415 | 002 | DAPTOMYCIN | DAPTOMYCIN | 达托霉素 | POWDER;INTRAVENOUS | 500MG/VIAL | XELLIA PHARMS APS | 2023-01-30 | Yes | Yes | RX | |
(ANDA) 217410 | 001 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 盐酸氟奋乃静 | TABLET;ORAL | 1MG | AJANTA PHARMA LTD | 2023-01-05 | No | No | RX | AB |
(ANDA) 217410 | 002 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 盐酸氟奋乃静 | TABLET;ORAL | 2.5MG | AJANTA PHARMA LTD | 2023-01-05 | No | No | RX | AB |
(ANDA) 217410 | 003 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 盐酸氟奋乃静 | TABLET;ORAL | 5MG | AJANTA PHARMA LTD | 2023-01-05 | No | No | RX | AB |
(ANDA) 217410 | 004 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 盐酸氟奋乃静 | TABLET;ORAL | 10MG | AJANTA PHARMA LTD | 2023-01-05 | No | No | RX | AB |
(ANDA) 217399 | 001 | OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 奥美沙坦酯 | TABLET;ORAL | 5MG | MSN | 2023-01-18 | No | No | RX | AB |
(ANDA) 217399 | 002 | OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 奥美沙坦酯 | TABLET;ORAL | 20MG | MSN | 2023-01-18 | No | No | RX | AB |
(ANDA) 217399 | 003 | OLMESARTAN MEDOXOMIL | OLMESARTAN MEDOXOMIL | 奥美沙坦酯 | TABLET;ORAL | 40MG | MSN | 2023-01-18 | No | No | RX | AB |
(ANDA) 217069 | 001 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 盐酸去氧肾上腺素 | SOLUTION;INTRAVENOUS | 10MG/ML (10MG/ML) | MANKIND PHARMA | 2022-08-30 | No | No | RX | AP1 |
(ANDA) 217069 | 002 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 盐酸去氧肾上腺素 | SOLUTION;INTRAVENOUS | 50MG/5ML (10MG/ML) | MANKIND PHARMA | 2022-08-30 | No | No | RX | AP1 |
(ANDA) 217069 | 003 | PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | 盐酸去氧肾上腺素 | SOLUTION;INTRAVENOUS | 100MG/10ML (10MG/ML) | MANKIND PHARMA | 2022-08-30 | No | No | RX | AP1 |
(ANDA) 217054 | 001 | DICYCLOMINE HYDROCHLORIDE | DICYCLOMINE HYDROCHLORIDE | 盐酸双环胺 | CAPSULE;ORAL | 10MG | TWI PHARMS | 2022-12-27 | No | No | RX | AB |
(ANDA) 217038 | 001 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 酮咯酸氨丁三醇 | TABLET;ORAL | 10MG | ZYDUS | 2022-10-21 | No | No | RX | AB |
(ANDA) 217029 | 001 | TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | 硫酸妥布霉素 | INJECTABLE;INJECTION | EQ 1.2GM BASE/VIAL | HAINAN POLY | 2023-02-01 | No | No | RX | AP |
(ANDA) 217027 | 001 | DETROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 天冬氨酸苯丙胺;硫酸苯丙胺;糖酸右苯丙胺;硫酸右苯丙胺 | CAPSULE, EXTENDED RELEASE;ORAL | 1.25MG;1.25MG;1.25MG;1.25MG | GRANULES | 2023-01-23 | No | No | RX | AB |
(ANDA) 217027 | 002 | DETROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 天冬氨酸苯丙胺;硫酸苯丙胺;糖酸右苯丙胺;硫酸右苯丙胺 | CAPSULE, EXTENDED RELEASE;ORAL | 2.5MG;2.5MG;2.5MG;2.5MG | GRANULES | 2023-01-23 | No | No | RX | AB |
(ANDA) 217027 | 003 | DETROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 天冬氨酸苯丙胺;硫酸苯丙胺;糖酸右苯丙胺;硫酸右苯丙胺 | CAPSULE, EXTENDED RELEASE;ORAL | 3.75MG;3.75MG;3.75MG;3.75MG | GRANULES | 2023-01-23 | No | No | RX | AB |