Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083633
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISONIAZID ISONIAZID 300MG TABLET;ORAL Discontinued None No No
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.

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