(NDA) 218550 | 001 | ROZLYTREK | ENTRECTINIB | PELLETS;ORAL | 50MG/PACKET | GENENTECH INC | 2023-10-20 | Yes | RX | |
(ANDA) 218149 | 001 | METHIMAZOLE | METHIMAZOLE | TABLET;ORAL | 5MG | BIONPHARMA | 2023-09-25 | No | RX | AB |
(ANDA) 218149 | 002 | METHIMAZOLE | METHIMAZOLE | TABLET;ORAL | 10MG | BIONPHARMA | 2023-09-25 | No | RX | AB |
(ANDA) 218122 | 001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | CAPSULE;ORAL | 2MG | AUROBINDO PHARMA LTD | 2023-09-05 | No | RX | AB |
(ANDA) 218055 | 001 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 1MG | AUROBINDO PHARMA LTD | 2023-08-18 | No | RX | AB |
(ANDA) 218055 | 002 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 2.5MG | AUROBINDO PHARMA LTD | 2023-08-18 | No | RX | AB |
(ANDA) 218055 | 003 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | AUROBINDO PHARMA LTD | 2023-08-18 | No | RX | AB |
(ANDA) 218055 | 004 | FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | AUROBINDO PHARMA LTD | 2023-08-18 | No | RX | AB |
(ANDA) 218036 | 001 | LITHIUM CITRATE | LITHIUM CITRATE | SYRUP;ORAL | EQ 300MG CARBONATE/5ML | RUBICON | 2023-08-14 | No | RX | AA |
(ANDA) 218024 | 001 | SUNITINIB MALATE | SUNITINIB MALATE | CAPSULE;ORAL | EQ 12.5MG BASE | NATCO PHARMA | 2023-10-24 | No | RX | AB |
(ANDA) 218024 | 002 | SUNITINIB MALATE | SUNITINIB MALATE | CAPSULE;ORAL | EQ 25MG BASE | NATCO PHARMA | 2023-10-24 | No | RX | AB |
(ANDA) 218024 | 003 | SUNITINIB MALATE | SUNITINIB MALATE | CAPSULE;ORAL | EQ 37.5MG BASE | NATCO PHARMA | 2023-10-24 | No | RX | AB |
(ANDA) 218024 | 004 | SUNITINIB MALATE | SUNITINIB MALATE | CAPSULE;ORAL | EQ 50MG BASE | NATCO PHARMA | 2023-10-24 | No | RX | AB |
(ANDA) 218015 | 001 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | TABLET;ORAL | 12.5MG;50MG | GRANULES | 2023-09-29 | No | RX | AB |
(ANDA) 218015 | 002 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | TABLET;ORAL | 12.5MG;100MG | GRANULES | 2023-09-29 | No | RX | AB |
(ANDA) 218015 | 003 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | TABLET;ORAL | 25MG;100MG | GRANULES | 2023-09-29 | No | RX | AB |
(ANDA) 218012 | 001 | SUNITINIB MALATE | SUNITINIB MALATE | CAPSULE;ORAL | EQ 12.5MG BASE | NOVUGEN | 2023-08-21 | No | RX | AB |
(ANDA) 218012 | 002 | SUNITINIB MALATE | SUNITINIB MALATE | CAPSULE;ORAL | EQ 25MG BASE | NOVUGEN | 2023-08-21 | No | RX | AB |
(ANDA) 218012 | 003 | SUNITINIB MALATE | SUNITINIB MALATE | CAPSULE;ORAL | EQ 37.5MG BASE | NOVUGEN | 2023-08-21 | No | RX | AB |
(ANDA) 218012 | 004 | SUNITINIB MALATE | SUNITINIB MALATE | CAPSULE;ORAL | EQ 50MG BASE | NOVUGEN | 2023-08-21 | No | RX | AB |