Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078630
Company: HIKMA FARMACEUTICA

• Other Important Information from FDA

Products on ANDA 078630

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078630

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/20/2009	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
04/08/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078630

TERBUTALINE SULFATE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TERBUTALINE SULFATE	TERBUTALINE SULFATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	200122	AREVA PHARMS
TERBUTALINE SULFATE	TERBUTALINE SULFATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	076887	FRESENIUS KABI USA
TERBUTALINE SULFATE	TERBUTALINE SULFATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	078630	HIKMA FARMACEUTICA