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Abbreviated New Drug Application (ANDA): 217022
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
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