Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087736
Company: HIKMA INTL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLOROTHIAZIDE CHLOROTHIAZIDE 500MG 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
07/14/1982 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
06/08/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/2000 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

09/06/1996 SUPPL-18 Labeling

Label is not available on this site.

05/24/1995 SUPPL-17 Labeling

Label is not available on this site.

05/04/1990 SUPPL-14 Labeling

Label is not available on this site.

11/14/1990 SUPPL-13 Bioequivalence

Label is not available on this site.

07/24/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/29/1992 SUPPL-11 Labeling

Label is not available on this site.

07/24/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/24/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/24/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/06/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/19/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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