Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215969
Company: SOMERSET THERAPS LLC

Products on ANDA 215969

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATROPINE SULFATE	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
ATROPINE SULFATE	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215969

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/03/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215969

ATROPINE SULFATE

SOLUTION;INTRAVENOUS; 0.4MG/ML (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	0.4MG/ML (0.4MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216120	AM REGENT
ATROPINE SULFATE	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217345	HIKMA
ATROPINE SULFATE	ATROPINE SULFATE	0.4MG/ML (0.4MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215969	SOMERSET THERAPS LLC

SOLUTION;INTRAVENOUS; 1MG/ML (1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATROPINE SULFATE	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	214652	ACCORD HLTHCARE
ATROPINE SULFATE	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216120	AM REGENT
ATROPINE SULFATE	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217345	HIKMA
ATROPINE SULFATE	ATROPINE SULFATE	1MG/ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215969	SOMERSET THERAPS LLC