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Details for New Drug Application (NDA): 072265

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NDA 072265 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 twenty-nine NDAs. It is available from thirty-two 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-four suppliers are listed for this compound. Additional details are available on the benztropine mesylate profile page.

Summary for NDA: 072265

Tradename:
BENZTROPINE MESYLATE
Applicant:
Corepharma
Ingredient:
benztropine mesylate
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 072265

Suppliers and Packaging for NDA: 072265

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZTROPINE MESYLATE
benztropine mesylate
TABLET;ORAL 072265 ANDA Major Pharmaceuticals 0904-1056 0904-1056-61 100 TABLET in 1 BOX, UNIT-DOSE (0904-1056-61)
BENZTROPINE MESYLATE
benztropine mesylate
TABLET;ORAL 072265 ANDA Major Pharmaceuticals 0904-1056 0904-1056-80 1000 TABLET in 1 BOTTLE (0904-1056-80)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Feb 27, 1989TE:AARLD:No


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