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Serving leading biopharmaceutical companies globally:

Queensland Health

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206289

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NDA 206289 describes ATROPINE SULFATE, which is a drug marketed by Us Army, Akorn, and Hospira, and is included in three NDAs. It is available from two suppliers. Additional details are available on the ATROPINE SULFATE profile page.

The generic ingredient in ATROPINE SULFATE is atropine sulfate. There are twenty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the atropine sulfate profile page.

Summary for 206289

Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 206289

Suppliers and Packaging for NDA: 206289

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATROPINE SULFATE atropine sulfate SOLUTION/DROPS;OPHTHALMIC 206289 NDA MWI 13985-606 13985-606-05 1 BOTTLE, DROPPER in 1 CARTON (13985-606-05) > 5 mL in 1 BOTTLE, DROPPER
ATROPINE SULFATE atropine sulfate SOLUTION/DROPS;OPHTHALMIC 206289 NDA Akorn, Inc. 17478-215 17478-215-02 1 BOTTLE, DROPPER in 1 CARTON (17478-215-02) > 2 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength1%
Approval Date:Jul 18, 2014TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
Harvard Business School

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