Details for New Drug Application (NDA): 213561

NDA 213561 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 213561

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

Pharmacology for NDA: 213561

Mechanism of Action

Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 213561

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	213561	ANDA	Hikma Pharmaceuticals USA Inc.	0641-6251	0641-6251-10	10 VIAL in 1 CARTON (0641-6251-10) / 20 mL in 1 VIAL
ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL	213561	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1619	51662-1619-1	20 mL in 1 VIAL (51662-1619-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL			Strength	8MG/20ML (0.4MG/ML)
Approval Date:	Dec 1, 2021	TE:	AP	RLD:	No

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