Drugs@FDA: FDA-Approved Drugs

Abbreviated New Drug Application (ANDA): 216120
Company: AM REGENT

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

Showing 1 to 2 of 2 entries

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
05/26/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.

Showing 1 to 1 of 1 entries

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	Yes	AP	214652	ACCORD HLTHCARE
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	215969	SOMERSET THERAPS LLC

Showing 1 to 3 of 3 entries

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	215969	SOMERSET THERAPS LLC

Showing 1 to 3 of 3 entries