Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071976
Company: IMPAX LABS INC

Products on ANDA 071976

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	AB	No	Yes
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071976

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/1988	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
01/22/2015	SUPPL-32	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/09/2014	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
01/07/2008	SUPPL-24	Labeling		Label is not available on this site.
03/20/2008	SUPPL-23	Labeling		Label is not available on this site.
05/24/2002	SUPPL-11	Labeling		Label is not available on this site.
06/08/2001	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
07/07/2000	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
11/22/1999	SUPPL-8	Labeling		Label is not available on this site.
06/10/1999	SUPPL-7	Labeling		Label is not available on this site.
10/20/1998	SUPPL-6	Labeling		Label is not available on this site.
05/11/1994	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/23/1992	SUPPL-4	Labeling		Label is not available on this site.
10/24/1991	SUPPL-3	Labeling		Label is not available on this site.
08/30/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 071976

PROPRANOLOL HYDROCHLORIDE

TABLET;ORAL; 80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	071976	IMPAX LABS INC
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	070322	INNOGENIX
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	078955	IPCA LABS LTD
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	216663	MANKIND PHARMA
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	070213	MYLAN
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	070221	PH HEALTH
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET;ORAL	Prescription	No	AB	070178	WATSON LABS

TABLET;ORAL; 60MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	071976	IMPAX LABS INC
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	070322	INNOGENIX
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	078955	IPCA LABS LTD
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	216663	MANKIND PHARMA
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	070213	MYLAN
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET;ORAL	Prescription	No	AB	070221	PH HEALTH