Details for New Drug Application (NDA): 214652

NDA 214652 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 214652

Tradename:	ATROPINE SULFATE
Applicant:	Accord Hlthcare
Ingredient:	atropine sulfate
Patents:	0

Pharmacology for NDA: 214652

Mechanism of Action

Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 214652

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS	214652	NDA	Henry Schein, Inc.	0404-9989	0404-9989-01	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9989-01) / 1 mL in 1 VIAL, SINGLE-DOSE
ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS	214652	NDA	Accord Healthcare Inc.	16729-525	16729-525-08	25 VIAL, SINGLE-DOSE in 1 CARTON (16729-525-08) / 1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	0.4MG/ML (0.4MG/ML)
Approval Date:	Sep 29, 2020	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1MG/ML (1MG/ML)
Approval Date:	Sep 29, 2020	TE:	AP	RLD:	Yes

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