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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 074165


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NDA 074165 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 074165
Tradename:CLOTRIMAZOLE
Applicant:P And L
Ingredient:clotrimazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074165
Medical Subject Heading (MeSH) Categories for 074165
Suppliers and Packaging for NDA: 074165
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOTRIMAZOLE clotrimazole CREAM;VAGINAL 074165 ANDA Walgreens 0363-0220 0363-0220-63 1 TUBE in 1 CARTON (0363-0220-63) / 45 g in 1 TUBE
CLOTRIMAZOLE clotrimazole CREAM;VAGINAL 074165 ANDA Rite Aid Corporation 11822-0220 11822-0220-6 1 TUBE in 1 CARTON (11822-0220-6) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CREAM;VAGINALStrength1%
Approval Date:Jul 16, 1993TE:RLD:No

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