Details for New Drug Application (NDA): 218148

NDA 218148 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 218148

Tradename:	ATROPINE SULFATE
Applicant:	Mankind Pharma
Ingredient:	atropine sulfate
Patents:	0

Pharmacology for NDA: 218148

Mechanism of Action

Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 218148

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	218148	ANDA	Lifestar Pharma LLC	70756-651	70756-651-25	1 BOTTLE in 1 CARTON (70756-651-25) / 2 mL in 1 BOTTLE
ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	218148	ANDA	Lifestar Pharma LLC	70756-652	70756-652-25	1 BOTTLE in 1 CARTON (70756-652-25) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	1%
Approval Date:	Jan 8, 2024	TE:	AT1	RLD:	No

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