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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213561
Company: HIKMA

Products on ANDA 213561

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATROPINE SULFATE	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213561

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/01/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213561

ATROPINE SULFATE

SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL; 8MG/20ML (0.4MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATROPINE SULFATE	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	Prescription	No	AP	213424	ACCORD HLTHCARE
ATROPINE SULFATE	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	Prescription	Yes	AP	209260	FRESENIUS KABI USA
ATROPINE SULFATE	ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	Prescription	No	AP	213561	HIKMA

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