Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087736
Company: HIKMA INTL PHARMS

Products on ANDA 087736

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLOROTHIAZIDE	CHLOROTHIAZIDE	500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087736

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.