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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204228
Company: AJANTA PHARMA LTD

Products on ANDA 204228

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	Prescription	AB	No	No
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG;1.1GM	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204228

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			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204228Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/15/2023	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
11/15/2023	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
11/15/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
02/24/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/24/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/24/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204228

OMEPRAZOLE AND SODIUM BICARBONATE

CAPSULE;ORAL; 20MG;1.1GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE;ORAL	Prescription	No	AB	204228	AJANTA PHARMA LTD
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE;ORAL	Prescription	No	AB	212587	ANDA REPOSITORY
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE;ORAL	Prescription	No	AB	204922	AUROLIFE PHARMA LLC
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE;ORAL	Prescription	No	AB	204068	DR REDDYS
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE;ORAL	Prescription	No	AB	207476	SCIEGEN PHARMS INC
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE;ORAL	Prescription	No	AB	203290	ZYDUS PHARMS

CAPSULE;ORAL; 40MG;1.1GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG;1.1GM	CAPSULE;ORAL	Prescription	No	AB	204228	AJANTA PHARMA LTD
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG;1.1GM	CAPSULE;ORAL	Prescription	No	AB	212587	ANDA REPOSITORY
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG;1.1GM	CAPSULE;ORAL	Prescription	No	AB	204922	AUROLIFE PHARMA LLC
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG;1.1GM	CAPSULE;ORAL	Prescription	No	AB	204068	DR REDDYS
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG;1.1GM	CAPSULE;ORAL	Prescription	No	AB	207476	SCIEGEN PHARMS INC
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	40MG;1.1GM	CAPSULE;ORAL	Prescription	No	AB	203290	ZYDUS PHARMS

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