Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217022
Company: ZHEJIANG YONGTAI
Company: ZHEJIANG YONGTAI
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | No | No |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/27/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ESOMEPRAZOLE MAGNESIUM
CAPSULE, DELAYED REL PELLETS;ORAL; EQ 20MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 208333 | ALKEM LABS LTD |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 205606 | AUROBINDO PHARMA LTD |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 213158 | CISEN |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 212949 | CSPC OUYI |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 078279 | DR REDDYS |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090841 | ETHYPHARM |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 217427 | GRANULES |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 213486 | GRAVITI PHARMS |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 213859 | GUANGZHOU NOVAKEN |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 211977 | HETERO LABS LTD III |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 210559 | INDCHEMIE HEALTH |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 078003 | IVAX SUB TEVA PHARMS |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 205563 | LANNETT CO INC |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 208511 | MACLEODS PHARMS LTD |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 078936 | MYLAN |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 214920 | PRINSTON INC |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 209735 | SUN PHARM |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 217022 | ZHEJIANG YONGTAI |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 206296 | ZYDUS PHARMS |
NEXIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | Yes | AB | 021153 | ASTRAZENECA |
CAPSULE, DELAYED REL PELLETS;ORAL; EQ 40MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 208333 | ALKEM LABS LTD |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 205606 | AUROBINDO PHARMA LTD |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 213158 | CISEN |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 212949 | CSPC OUYI |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 078279 | DR REDDYS |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090841 | ETHYPHARM |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 217427 | GRANULES |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 213486 | GRAVITI PHARMS |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 213859 | GUANGZHOU NOVAKEN |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 211977 | HETERO LABS LTD III |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 210559 | INDCHEMIE HEALTH |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 078003 | IVAX SUB TEVA PHARMS |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 205563 | LANNETT CO INC |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 208511 | MACLEODS PHARMS LTD |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 078936 | MYLAN |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 214920 | PRINSTON INC |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 209735 | SUN PHARM |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 217022 | ZHEJIANG YONGTAI |
ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 206296 | ZYDUS PHARMS |
NEXIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | Yes | AB | 021153 | ASTRAZENECA |