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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089058

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NDA 089058 describes BENZTROPINE MESYLATE, which is a drug marketed by Fresenius Kabi Usa, Hikma Farmaceutica, Luitpold, Navinta Llc, Anda Repository, Aspen Global Inc, Epic Pharma Llc, Invagen Pharms, Lannett Holdings Inc, Leading Pharma Llc, Oxford Pharms, Pliva, Quantum Pharmics, Usl Pharma, and Vintage, and is included in twenty-seven NDAs. It is available from thirty-one suppliers. Additional details are available on the BENZTROPINE MESYLATE profile page.

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

Summary for 089058

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 089058

Medical Subject Heading (MeSH) Categories for 089058

Suppliers and Packaging for NDA: 089058

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZTROPINE MESYLATE benztropine mesylate TABLET;ORAL 089058 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-2547 0615-2547-31 31 TABLET in 1 BLISTER PACK (0615-2547-31)
BENZTROPINE MESYLATE benztropine mesylate TABLET;ORAL 089058 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-2547 0615-2547-39 30 TABLET in 1 BLISTER PACK (0615-2547-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Aug 10, 1988TE:AARLD:No


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