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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215342
Company: AMNEAL

Products on ANDA 215342

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATROPINE SULFATE	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
ATROPINE SULFATE	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215342

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215342Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 215342

ATROPINE SULFATE

SOLUTION;INTRAVENOUS; 0.5MG/5ML (0.1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATROPINE SULFATE	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212868	ACCORD HLTHCARE
ATROPINE SULFATE	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215342	AMNEAL
ATROPINE SULFATE	ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	021146	HOSPIRA

SOLUTION;INTRAVENOUS; 1MG/10ML (0.1MG/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/10ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212868	ACCORD HLTHCARE
ATROPINE SULFATE	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215342	AMNEAL
ATROPINE SULFATE	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	021146	HOSPIRA
ATROPINE SULFATE	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212461	INTL MEDICATION SYS
ATROPINE SULFATE	ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214970	MEDEFIL INC

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