Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070852
Company: ACTAVIS ELIZABETH

Products on ANDA 070852

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE	25MG;80MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070852

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/15/1986	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
08/26/2002	SUPPL-17	Labeling		Label is not available on this site.
11/02/2001	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
06/13/2001	SUPPL-13	Labeling		Label is not available on this site.
08/11/1998	SUPPL-12	Labeling		Label is not available on this site.
01/18/1996	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
11/21/1991	SUPPL-10	Labeling		Label is not available on this site.
09/18/1991	SUPPL-9	Labeling		Label is not available on this site.
08/15/1989	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/15/1989	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/15/1989	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
11/08/1988	SUPPL-5	Labeling		Label is not available on this site.
11/08/1988	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/08/1988	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/17/1987	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.