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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 217791

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NDA 217791 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 217791

Tradename:	ATROPINE SULFATE
Applicant:	Somerset
Ingredient:	atropine sulfate
Patents:	0

Pharmacology for NDA: 217791

Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 217791

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	217791	ANDA	Somerset Therapeutics, LLC	70069-716	70069-716-01	1 BOTTLE in 1 CARTON (70069-716-01) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	1%
Approval Date:	Apr 29, 2024	TE:	AT2	RLD:	No

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