Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080212
Company: HIKMA INTL PHARMS
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
02/28/1972 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
10/31/2008 SUPPL-37 Labeling

Label is not available on this site.

10/01/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

08/13/1997 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/13/1997 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

02/18/1997 SUPPL-29 Labeling

Label is not available on this site.

06/23/1995 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/23/1995 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/23/1995 SUPPL-26 Labeling

Label is not available on this site.

06/23/1995 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/23/1995 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/23/1995 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/23/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/23/1995 SUPPL-21 Labeling

Label is not available on this site.

10/23/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/23/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/23/1995 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/15/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/28/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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