Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080136
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISONIAZID ISONIAZID 100MG 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
11/13/1970 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-36 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2002 SUPPL-35 Manufacturing (CMC)-Facility

Label is not available on this site.

09/24/2001 SUPPL-34 Manufacturing (CMC)-Facility

Label is not available on this site.

11/02/2001 SUPPL-33 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2000 SUPPL-32 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2000 SUPPL-31 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2000 SUPPL-30 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2000 SUPPL-29 Manufacturing (CMC)-Facility

Label is not available on this site.

03/17/1998 SUPPL-28 Labeling

Label is not available on this site.

03/11/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

07/31/1992 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/10/1994 SUPPL-25 Labeling

Label is not available on this site.

12/09/1988 SUPPL-24 Labeling

Label is not available on this site.

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