Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084912
Company: CHARTWELL RX

Products on ANDA 084912

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084912

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/1976	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-71	Labeling-Package Insert		Label is not available on this site.
08/06/2020	SUPPL-70	Labeling-Package Insert		Label is not available on this site.
12/01/1998	SUPPL-69	Manufacturing (CMC)		Label is not available on this site.
12/01/1998	SUPPL-68	Manufacturing (CMC)		Label is not available on this site.
01/12/1998	SUPPL-67	Manufacturing (CMC)		Label is not available on this site.
07/27/1995	SUPPL-66	Labeling		Label is not available on this site.
01/24/1994	SUPPL-65	Manufacturing (CMC)		Label is not available on this site.
03/30/1994	SUPPL-64	Labeling		Label is not available on this site.
08/11/1992	SUPPL-63	Labeling		Label is not available on this site.
11/09/1989	SUPPL-62	Labeling		Label is not available on this site.
11/21/1989	SUPPL-61	Labeling		Label is not available on this site.
08/23/1989	SUPPL-60	Labeling		Label is not available on this site.
05/27/1988	SUPPL-59	Labeling		Label is not available on this site.
08/21/1990	SUPPL-58	Manufacturing (CMC)		Label is not available on this site.
08/21/1990	SUPPL-57	Manufacturing (CMC)		Label is not available on this site.
06/03/1987	SUPPL-56	Manufacturing (CMC)		Label is not available on this site.
06/03/1987	SUPPL-55	Manufacturing (CMC)		Label is not available on this site.
06/03/1987	SUPPL-54	Manufacturing (CMC)		Label is not available on this site.
06/03/1987	SUPPL-53	Manufacturing (CMC)		Label is not available on this site.
04/12/1985	SUPPL-50	Manufacturing (CMC)		Label is not available on this site.
04/23/1985	SUPPL-49	Manufacturing (CMC)		Label is not available on this site.
08/17/1983	SUPPL-46	Manufacturing (CMC)		Label is not available on this site.
08/17/1983	SUPPL-45	Manufacturing (CMC)		Label is not available on this site.
08/09/1982	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
07/08/1982	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
07/08/1982	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
07/08/1982	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
07/08/1982	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.