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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216349
Company: GRAVITI PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter None 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
06/24/2022 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/15/2023 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

ESOMEPRAZOLE MAGNESIUM

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE, DELAYED RELEASE;ORAL; EQ 20MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 209716 AMNEAL PHARMS NY
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 216149 ANDA REPOSITORY
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 209339 AUROBINDO PHARMA
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 207198 DR REDDYS
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 207673 DR REDDYS
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 218092 GLENMARK SPECLT
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 216349 GRAVITI PHARMS
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 212507 HETERO LABS LTD III
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 207193 PERRIGO R AND D
ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter No 212866 SUN PHARM
NEXIUM 24HR ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE;ORAL Over-the-counter Yes 204655 ASTRAZENECA LP
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