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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 215618


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NDA 215618 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 215618
Tradename:ATROPINE SULFATE
Applicant:Somerset Theraps Llc
Ingredient:atropine sulfate
Patents:0
Pharmacology for NDA: 215618
Suppliers and Packaging for NDA: 215618
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATROPINE SULFATE atropine sulfate SOLUTION/DROPS;OPHTHALMIC 215618 ANDA Somerset Therapeutics, LLC 70069-581 70069-581-01 1 BOTTLE in 1 CARTON (70069-581-01) / 2 mL in 1 BOTTLE
ATROPINE SULFATE atropine sulfate SOLUTION/DROPS;OPHTHALMIC 215618 ANDA Somerset Therapeutics, LLC 70069-582 70069-582-01 1 BOTTLE in 1 CARTON (70069-582-01) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength1%
Approval Date:Jul 1, 2024TE:AT1RLD:No

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