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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203290
Company: ZYDUS PHARMS

Products on ANDA 203290

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203290

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/25/2018	ORIG-1	Approval				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-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/15/2023	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/15/2023	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 203290

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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