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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 215624


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NDA 215624 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 215624
Tradename:ATROPINE SULFATE
Applicant:Apotex
Ingredient:atropine sulfate
Patents:0
Pharmacology for NDA: 215624
Mechanism of ActionCholinergic Antagonists
Cholinergic Muscarinic Antagonists
Suppliers and Packaging for NDA: 215624
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATROPINE SULFATE atropine sulfate SOLUTION/DROPS;OPHTHALMIC 215624 ANDA A-S Medication Solutions 50090-7000 50090-7000-0 1 BOTTLE, DROPPER in 1 CARTON (50090-7000-0) / 5 mL in 1 BOTTLE, DROPPER
ATROPINE SULFATE atropine sulfate SOLUTION/DROPS;OPHTHALMIC 215624 ANDA Apotex Corp. 60505-6226 60505-6226-0 1 BOTTLE, DROPPER in 1 CARTON (60505-6226-0) / 2 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength1%
Approval Date:Nov 26, 2021TE:AT1RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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