Details for New Drug Application (NDA): 214970

NDA 214970 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 214970

Tradename:	ATROPINE SULFATE
Applicant:	Medefil Inc
Ingredient:	atropine sulfate
Patents:	0

Pharmacology for NDA: 214970

Mechanism of Action

Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 214970

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS	214970	ANDA	Medefil, Inc.	64253-400	64253-400-91	10 SYRINGE, PLASTIC in 1 BOX (64253-400-91) / 10 mL in 1 SYRINGE, PLASTIC (64253-400-30)
ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS	214970	ANDA	ProPharma Distribution	84549-400	84549-400-91	10 mL in 1 SYRINGE, PLASTIC (84549-400-91)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1MG/10ML (0.1MG/ML)
Approval Date:	Nov 4, 2022	TE:	AP	RLD:	No

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