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Last Updated: December 8, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 012015

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NDA 012015 describes COGENTIN, which is a drug marketed by Oak Pharms Akorn and Merck and is included in two NDAs. It is available from two suppliers. Additional details are available on the COGENTIN profile page.

The generic ingredient in COGENTIN is benztropine mesylate. There are seven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the benztropine mesylate profile page.
Summary for 012015
Applicant:Oak Pharms Akorn
Ingredient:benztropine mesylate
Formulation / Manufacturing:see details
Pharmacology for NDA: 012015
Medical Subject Heading (MeSH) Categories for 012015
Suppliers and Packaging for NDA: 012015
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COGENTIN benztropine mesylate INJECTABLE;INJECTION 012015 NDA AUTHORIZED GENERIC Akorn, Inc. 17478-012 17478-012-02 5 AMPULE in 1 CARTON (17478-012-02) > 2 mL in 1 AMPULE
COGENTIN benztropine mesylate INJECTABLE;INJECTION 012015 NDA Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) 76478-611 76478-611-02 5 AMPULE in 1 CARTON (76478-611-02) > 2 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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