Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076770
Company: CHARTWELL INJECTABLE

• Other Important Information from FDA

Products on ANDA 076770

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 076770

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76770ltr.pdf

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 076770

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	076770	CHARTWELL INJECTABLE
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