Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084217
Company: MYLAN

Products on ANDA 084217

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLOROTHIAZIDE	CHLOROTHIAZIDE	500MG	TABLET;ORAL	Discontinued	None	No	No
CHLOROTHIAZIDE	CHLOROTHIAZIDE	250MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084217

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/17/1975	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
04/04/2005	SUPPL-198	Labeling		Label is not available on this site.
02/14/2001	SUPPL-196	Labeling		Label is not available on this site.
01/25/2001	SUPPL-195	Manufacturing (CMC)-Control		Label is not available on this site.
02/25/1998	SUPPL-194	Manufacturing (CMC)		Label is not available on this site.
02/05/1998	SUPPL-193	Manufacturing (CMC)		Label is not available on this site.
02/12/1996	SUPPL-192	Labeling		Label is not available on this site.
03/11/1994	SUPPL-191	Labeling		Label is not available on this site.
02/22/1994	SUPPL-190	Manufacturing (CMC)		Label is not available on this site.
03/01/1993	SUPPL-188	Labeling		Label is not available on this site.
12/06/1989	SUPPL-187	Labeling		Label is not available on this site.
01/31/1990	SUPPL-185	Manufacturing (CMC)		Label is not available on this site.
11/10/1987	SUPPL-183	Manufacturing (CMC)		Label is not available on this site.
09/18/1984	SUPPL-179	Manufacturing (CMC)		Label is not available on this site.
02/17/1983	SUPPL-178	Manufacturing (CMC)		Label is not available on this site.
03/26/1982	SUPPL-177	Manufacturing (CMC)		Label is not available on this site.
07/13/1989	SUPPL-88	Bioequivalence		Label is not available on this site.