Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077760
Company: HIKMA FARMACEUTICA

Products on ANDA 077760

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077760

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/2008	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
07/01/2015	SUPPL-8	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077760

PROPRANOLOL HYDROCHLORIDE

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075826	FRESENIUS KABI USA
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	077760	HIKMA FARMACEUTICA