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Details for New Drug Application (NDA): 091152

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NDA 091152 describes BENZTROPINE MESYLATE, which is a drug marketed by Usl Pharma, Oxford Pharms, Quantum Pharmics, Aspen Global Inc, Vintage, Navinta Llc, Fresenius Kabi Usa, Luitpold, Pliva, Corepharma, Frontida Biopharm, Leading Pharma Llc, Lannett Holdings Inc, Hikma Farmaceutica, and Invagen Pharms, and is included in thirty-one NDAs. It is available from thirty-three 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-five suppliers are listed for this compound. Additional details are available on the benztropine mesylate profile page.

Summary for NDA: 091152

benztropine mesylate
Therapeutic Class:Antiparkinson Agents

Pharmacology for NDA: 091152

Suppliers and Packaging for NDA: 091152

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
benztropine mesylate
INJECTABLE;INJECTION 091152 ANDA American Regent, Inc. 0517-0785 0517-0785-05 5 VIAL, SINGLE-USE in 1 CARTON (0517-0785-05) > 2 mL in 1 VIAL, SINGLE-USE (0517-0785-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Mar 29, 2010TE:APRLD:No

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