Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085683
Company: CHARTWELL RX

Products on ANDA 085683

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085683

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/1977	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
08/20/2020	SUPPL-58	Labeling-Package Insert		Label is not available on this site.
10/06/2000	SUPPL-57	Manufacturing (CMC)-Facility		Label is not available on this site.
03/13/1996	SUPPL-54	Labeling		Label is not available on this site.
08/02/1995	SUPPL-53	Labeling		Label is not available on this site.
03/13/1995	SUPPL-52	Labeling		Label is not available on this site.
07/15/1993	SUPPL-50	Labeling		Label is not available on this site.
11/13/1991	SUPPL-48	Labeling		Label is not available on this site.
07/25/1991	SUPPL-47	Labeling		Label is not available on this site.
12/04/1990	SUPPL-46	Labeling		Label is not available on this site.
08/03/1990	SUPPL-45	Labeling		Label is not available on this site.
01/31/1990	SUPPL-44	Labeling		Label is not available on this site.
03/24/1989	SUPPL-43	Labeling		Label is not available on this site.
05/02/1989	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.
01/23/1989	SUPPL-41	Labeling		Label is not available on this site.
03/24/1988	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
06/06/1983	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.