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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075791
Company: SANDOZ

Products on ANDA 075791

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS; ORAL	None (Tentative Approval)	None	No	No
OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075791

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/2002	ORIG-1	Approval				Label is not available on this site.

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