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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080132
Company: PUREPAC PHARM

Products on ANDA 080132

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISONIAZID	ISONIAZID	50MG	TABLET;ORAL	Discontinued	None	No	No
ISONIAZID	ISONIAZID	100MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080132

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Note
01/09/1985	SUPPL-18	Manufacturing (CMC)	Label is not available on this site.
07/14/1982	SUPPL-15	Manufacturing (CMC)	Label is not available on this site.
03/04/1982	SUPPL-13	Manufacturing (CMC)	Label is not available on this site.

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