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Last Updated: March 28, 2024

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, P And L, Novitium Pharma, Sciegen Pharms Inc, Tasman Pharma, Teva, Hikma, Padagis Us, and Actavis Mid Atlantic, and is included in eighteen NDAs. It is available from twenty-three 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. Fifteen 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 090219
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 Glenmark Pharmaceuticals Inc., USA 68462-181 68462-181-17 15 g in 1 TUBE (68462-181-17)
CLOTRIMAZOLE clotrimazole CREAM;TOPICAL 090219 ANDA Glenmark Pharmaceuticals Inc., USA 68462-181 68462-181-35 30 g in 1 TUBE (68462-181-35)

Profile for product number 001

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

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