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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205070
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS;ORAL Discontinued None No No
OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS;ORAL Discontinued None No No
OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS;ORAL Discontinued 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
06/29/2018 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
03/04/2022 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/27/2020 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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