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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 217345


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NDA 217345 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 217345
Tradename:ATROPINE SULFATE
Applicant:Hikma
Ingredient:atropine sulfate
Patents:0
Pharmacology for NDA: 217345
Mechanism of ActionCholinergic Antagonists
Cholinergic Muscarinic Antagonists
Suppliers and Packaging for NDA: 217345
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATROPINE SULFATE atropine sulfate SOLUTION;INTRAVENOUS 217345 ANDA Hikma Pharmaceuticals USA Inc. 0641-6274 0641-6274-25 25 VIAL in 1 CARTON (0641-6274-25) / 1 mL in 1 VIAL (0641-6274-01)
ATROPINE SULFATE atropine sulfate SOLUTION;INTRAVENOUS 217345 ANDA Hikma Pharmaceuticals USA Inc. 0641-6275 0641-6275-25 25 VIAL in 1 CARTON (0641-6275-25) / 1 mL in 1 VIAL (0641-6275-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.4MG/ML (0.4MG/ML)
Approval Date:Oct 24, 2025TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength1MG/ML (1MG/ML)
Approval Date:Oct 24, 2025TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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