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Julphar
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McKinsey
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Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090219

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NDA 090219 describes CLOTRIMAZOLE, which is a drug marketed by Fougera Pharms, Glenmark Pharms, Taro, Actavis Mid Atlantic, Teva, Paddock Llc, and West-ward Pharms Int, and is included in fifteen NDAs. It is available from eighteen suppliers. Additional details are available on the CLOTRIMAZOLE profile page.

The generic ingredient in CLOTRIMAZOLE is betamethasone dipropionate; clotrimazole. There are sixty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.
Summary for 090219
Tradename:CLOTRIMAZOLE
Applicant:Glenmark Pharms
Ingredient:clotrimazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 090219
Ingredient-typeAzoles
Medical Subject Heading (MeSH) Categories for 090219
Suppliers and Packaging for NDA: 090219
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOTRIMAZOLE clotrimazole CREAM;TOPICAL 090219 ANDA Lake Erie Medical DBA Quality Care Products LLC 49999-170 N 49999-170-30
CLOTRIMAZOLE clotrimazole CREAM;TOPICAL 090219 ANDA Glenmark Pharmaceuticals Inc., USA 68462-181 N 68462-181-47

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Aug 3, 2010TE:ABRLD:No

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US Army
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Fish and Richardson
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