Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070177
Company: WATSON LABS

Products on ANDA 070177

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070177

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/13/1986	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
05/18/2015	SUPPL-49	Labeling-Package Insert		Label is not available on this site.
07/14/2008	SUPPL-36	Labeling		Label is not available on this site.
05/03/2005	SUPPL-29	Labeling		Label is not available on this site.
06/27/2002	SUPPL-25	Labeling		Label is not available on this site.
04/25/2001	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
10/28/1999	SUPPL-23	Labeling		Label is not available on this site.
09/08/1998	SUPPL-21	Labeling		Label is not available on this site.
02/18/1993	SUPPL-19	Labeling		Label is not available on this site.
06/21/1991	SUPPL-16	Labeling		Label is not available on this site.
03/21/1991	SUPPL-15	Labeling		Label is not available on this site.
01/28/1991	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/07/1991	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
05/08/1989	SUPPL-11	Labeling		Label is not available on this site.
06/29/1988	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/29/1988	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/22/1988	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/08/1989	SUPPL-7	Labeling		Label is not available on this site.
03/25/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/22/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 070177

PROPRANOLOL HYDROCHLORIDE

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	070221	ENDO OPERATIONS
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	071972	IMPAX LABS INC
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	070322	INNOGENIX
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	078955	IPCA LABS LTD
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	070213	MYLAN
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	078213	NORTHSTAR HLTHCARE
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	070219	VINTAGE PHARMS
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	070177	WATSON LABS