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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201361
Company: PERRIGO R AND D

Products on ANDA 201361

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201361

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/15/2016	ORIG-1	Approval	Not Applicable		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201361Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201361Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/05/2024	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
02/05/2024	SUPPL-15	Labeling-Container/Carton Labels		Label is not available on this site.
02/05/2024	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/05/2024	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 201361

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/15/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201361Orig1s000lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

OMEPRAZOLE AND SODIUM BICARBONATE

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

CAPSULE;ORAL; 20MG;1.1GM

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE;ORAL	Over-the-counter	No	204923	AUROBINDO PHARMA
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE;ORAL	Over-the-counter	No	201361	PERRIGO R AND D
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE;ORAL	Over-the-counter	No	203345	ZYDUS
ZEGERID OTC	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE;ORAL	Over-the-counter	Yes	022281	RILEY CONSUMER

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