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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 212868


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NDA 212868 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 212868
Tradename:ATROPINE SULFATE
Applicant:Accord Hlthcare
Ingredient:atropine sulfate
Patents:0
Pharmacology for NDA: 212868
Suppliers and Packaging for NDA: 212868
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATROPINE SULFATE atropine sulfate SOLUTION;INTRAVENOUS 212868 ANDA Accord Healthcare, Inc., 16729-483 16729-483-03 10 SYRINGE, GLASS in 1 CARTON (16729-483-03) / 5 mL in 1 SYRINGE, GLASS
ATROPINE SULFATE atropine sulfate SOLUTION;INTRAVENOUS 212868 ANDA Accord Healthcare, Inc., 16729-483 16729-483-31 5 mL in 1 SYRINGE, GLASS (16729-483-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.25MG/5ML (0.05MG/ML)
Approval Date:Jul 26, 2021TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.5MG/5ML (0.1MG/ML)
Approval Date:Jul 26, 2021TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength1MG/10ML (0.1MG/ML)
Approval Date:Jul 26, 2021TE:APRLD:No

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