Details for New Drug Application (NDA): 216120

NDA 216120 describes ATROPINE SULFATE, which is a drug marketed by Us Army, Amneal, Apotex, Bausch And Lomb Inc, Mankind Pharma, Rising, Somerset, Somerset Theraps Llc, Accord Hlthcare, Am Regent, Hikma, Hospira, Intl Medication Sys, Medefil Inc, and Fresenius Kabi Usa, and is included in twenty-one NDAs. It is available from twenty-four suppliers. Additional details are available on the ATROPINE SULFATE profile page.

The generic ingredient in ATROPINE SULFATE is atropine sulfate. There are twenty-three drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the atropine sulfate profile page.

Summary for 216120

Tradename:	ATROPINE SULFATE
Applicant:	Am Regent
Ingredient:	atropine sulfate
Patents:	0

Pharmacology for NDA: 216120

Mechanism of Action

Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 216120

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS	216120	ANDA	Henry Schein, Inc	0404-9802	0404-9802-01	1 VIAL, GLASS in 1 BAG (0404-9802-01) / 1 mL in 1 VIAL, GLASS
ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS	216120	ANDA	American Regent, Inc.	0517-1001	0517-1001-25	25 VIAL, GLASS in 1 TRAY (0517-1001-25) / 1 mL in 1 VIAL, GLASS (0517-1001-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	0.4MG/ML (0.4MG/ML)
Approval Date:	May 26, 2022	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1MG/ML (1MG/ML)
Approval Date:	May 26, 2022	TE:	AP	RLD:	No

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