Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210070
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMEPRAZOLE OMEPRAZOLE 20MG TABLET, DELAYED RELEASE;ORAL Over-the-counter AP1 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
02/11/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

OMEPRAZOLE

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

TABLET, DELAYED RELEASE;ORAL; 20MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
OMEPRAZOLE OMEPRAZOLE 20MG TABLET, DELAYED RELEASE;ORAL Over-the-counter No 210070 APOTEX INC
OMEPRAZOLE OMEPRAZOLE 20MG TABLET, DELAYED RELEASE;ORAL Over-the-counter Yes 022032 DEXCEL PHARMA
OMEPRAZOLE OMEPRAZOLE 20MG TABLET, DELAYED RELEASE;ORAL Over-the-counter No 207740 DR REDDYS LABS LTD
OMEPRAZOLE OMEPRAZOLE 20MG TABLET, DELAYED RELEASE;ORAL Over-the-counter No 207891 SUN PHARM

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