Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008428
Company: PANRAY

Products on NDA 008428

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
ISONIAZID	ISONIAZID	300MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 008428

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/1980	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
06/14/1979	SUPPL-22	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
11/07/1978	SUPPL-20	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/19/1978	SUPPL-15	Labeling		Label is not available on this site.
06/19/1978	SUPPL-14	Labeling		Label is not available on this site.
06/13/1978	SUPPL-13	Labeling		Label is not available on this site.
04/20/1978	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
07/25/1977	SUPPL-10	Labeling		Label is not available on this site.
04/06/1977	SUPPL-9	Labeling		Label is not available on this site.
04/13/1977	SUPPL-8	Labeling		Label is not available on this site.
03/01/1976	SUPPL-7	Labeling		Label is not available on this site.
06/11/1973	SUPPL-3			Label is not available on this site.