You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for New Drug Application (NDA): 076387


✉ Email this page to a colleague

« Back to Dashboard


NDA 076387 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 076387
Tradename:CLOTRIMAZOLE
Applicant:Hikma
Ingredient:clotrimazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076387
Medical Subject Heading (MeSH) Categories for 076387
Suppliers and Packaging for NDA: 076387
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOTRIMAZOLE clotrimazole TROCHE/LOZENGE;ORAL 076387 ANDA Hikma Pharmacuticals USA USA Inc. 0054-4146 0054-4146-22 70 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-22)
CLOTRIMAZOLE clotrimazole TROCHE/LOZENGE;ORAL 076387 ANDA Hikma Pharmacuticals USA USA Inc. 0054-4146 0054-4146-23 140 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-23)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TROCHE/LOZENGE;ORALStrength10MG
Approval Date:Jul 29, 2004TE:ABRLD: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.