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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090294

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NDA 090294 describes BENZTROPINE MESYLATE, which is a drug marketed by Fresenius Kabi Usa, Hikma Farmaceutica, Luitpold, Navinta Llc, Aspen Global Inc, Chartwell Rx, Epic Pharma Llc, Invagen Pharms, Lannett Co Inc, Leading Pharma Llc, Oxford Pharms, Pliva, Quantum Pharmics, Usl Pharma, and Vintage, and is included in twenty-seven NDAs. It is available from twenty-nine suppliers. Additional details are available on the BENZTROPINE MESYLATE profile page.

The generic ingredient in BENZTROPINE MESYLATE is benztropine mesylate. There are six drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the benztropine mesylate profile page.
Summary for 090294
Tradename:BENZTROPINE MESYLATE
Applicant:Invagen Pharms
Ingredient:benztropine mesylate
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090294
Medical Subject Heading (MeSH) Categories for 090294
Suppliers and Packaging for NDA: 090294
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZTROPINE MESYLATE benztropine mesylate TABLET;ORAL 090294 ANDA Camber Pharmaceutical, Inc. 31722-218 E 31722-218-01
BENZTROPINE MESYLATE benztropine mesylate TABLET;ORAL 090294 ANDA Camber Pharmaceutical, Inc. 31722-218 E 31722-218-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Mar 29, 2010TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Mar 29, 2010TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Mar 29, 2010TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
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US Army
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US Department of Justice
Covington

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