Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087425
Company: HIKMA INTL PHARMS
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
07/14/1981 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
10/21/2008 SUPPL-31 Labeling

Label is not available on this site.

10/01/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/12/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/12/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/08/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/08/1997 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/18/1997 SUPPL-21 Labeling

Label is not available on this site.

08/12/1997 SUPPL-20 Labeling

Label is not available on this site.

08/12/1997 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.

10/23/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/23/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/23/1995 SUPPL-15 Labeling

Label is not available on this site.

10/23/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/23/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/23/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

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