Details for New Drug Application (NDA): 213581

NDA 213581 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, Hospira, Intl Medication Sys, Medefil Inc, Fresenius Kabi Usa, and Hikma, and is included in nineteen NDAs. It is available from twenty-two 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-three suppliers are listed for this compound. Additional details are available on the atropine sulfate profile page.

Summary for 213581

Tradename:	ATROPINE SULFATE
Applicant:	Bausch And Lomb Inc
Ingredient:	atropine sulfate
Patents:	0

Pharmacology for NDA: 213581

Mechanism of Action

Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 213581

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	213581	NDA	Bausch & Lomb Incorporated	24208-965	24208-965-01	10 VIAL in 1 CARTON (24208-965-01) / .4 mL in 1 VIAL
ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	213581	NDA	Bausch & Lomb Americas Inc.	82260-001	82260-001-01	10 VIAL in 1 CARTON (82260-001-01) / .4 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	1%
Approval Date:	Mar 15, 2022	TE:		RLD:	Yes

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