Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083633
Company: SUN PHARM INDUSTRIES

Products on ANDA 083633

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISONIAZID	ISONIAZID	300MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083633

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/1976	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
07/24/2002	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
02/08/2002	SUPPL-20	Manufacturing (CMC)-Facility		Label is not available on this site.
09/24/2001	SUPPL-19	Manufacturing (CMC)-Facility		Label is not available on this site.
11/02/2001	SUPPL-18	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-17	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-16	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-15	Manufacturing (CMC)-Facility		Label is not available on this site.
12/18/2000	SUPPL-14	Manufacturing (CMC)-Facility		Label is not available on this site.
03/17/1998	SUPPL-13	Labeling		Label is not available on this site.
03/11/1997	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
07/31/1992	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/10/1994	SUPPL-10	Labeling		Label is not available on this site.
12/09/1988	SUPPL-9	Labeling		Label is not available on this site.
07/19/1982	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.