You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 21, 2024

Details for New Drug Application (NDA): 216569


✉ Email this page to a colleague

« Back to Dashboard


NDA 216569 describes CLOTRIMAZOLE, which is a drug marketed by Fougera Pharms, Glenmark Pharms, Taro, P And L, Novitium Pharma, Sciegen Pharms Inc, Teva, Trupharma, Hikma, Padagis Us, Thinq Pharm-cro Pvt, Actavis Mid Atlantic, and Glenmark Speclt, and is included in nineteen NDAs. It is available from twenty-four 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 216569
Tradename:CLOTRIMAZOLE
Applicant:Sciegen Pharms Inc
Ingredient:clotrimazole
Patents:0
Pharmacology for NDA: 216569
Medical Subject Heading (MeSH) Categories for 216569
Suppliers and Packaging for NDA: 216569
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOTRIMAZOLE clotrimazole SOLUTION;TOPICAL 216569 ANDA ScieGen Pharmaceuticals, Inc 50228-502 50228-502-08 1 BOTTLE in 1 CARTON (50228-502-08) / 10 mL in 1 BOTTLE
CLOTRIMAZOLE clotrimazole SOLUTION;TOPICAL 216569 ANDA ScieGen Pharmaceuticals, Inc 50228-502 50228-502-30 1 BOTTLE in 1 CARTON (50228-502-30) / 30 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength1%
Approval Date:Oct 16, 2023TE:ATRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.