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Generated: December 15, 2018

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Details for New Drug Application (NDA): 090287

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NDA 090287 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-six NDAs. It is available from twenty-seven 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the benztropine mesylate profile page.
Summary for 090287
Tradename:BENZTROPINE MESYLATE
Applicant:Hikma Farmaceutica
Ingredient:benztropine mesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090287
Medical Subject Heading (MeSH) Categories for 090287
Suppliers and Packaging for NDA: 090287
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZTROPINE MESYLATE benztropine mesylate INJECTABLE;INJECTION 090287 ANDA West-Ward Pharmaceuticals Corp 0143-9729 0143-9729-05 5 AMPULE in 1 CARTON (0143-9729-05) > 2 mL in 1 AMPULE (0143-9729-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Aug 31, 2009TE:APRLD:No

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