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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 three suppliers. Additional details are available on the COGENTIN profile page.

The generic ingredient in COGENTIN is benztropine mesylate. There are five drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the benztropine mesylate profile page.

Summary for NDA: 012015

Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 012015

Suppliers and Packaging for NDA: 012015

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
benztropine mesylate
INJECTABLE;INJECTION 012015 NDA AUTHORIZED GENERIC TYA Pharmaceuticals 64725-0012 64725-0012-1 5 mL in 1 CARTON (64725-0012-1)

Summary 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.