Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071060
Company: CHARTWELL RX

Products on ANDA 071060

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE	25MG;40MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071060

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/26/1987	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-16	Labeling-Package Insert		Label is not available on this site.
08/06/2020	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
05/09/2001	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
09/08/1998	SUPPL-11	Labeling		Label is not available on this site.
12/31/1998	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/31/1998	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/27/1995	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/26/1992	SUPPL-7	Labeling		Label is not available on this site.
11/25/1991	SUPPL-6	Labeling		Label is not available on this site.
06/27/1989	SUPPL-5	Labeling		Label is not available on this site.
10/13/1988	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/13/1988	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/19/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.