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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 018183


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NDA 018183 describes MYCELEX, which is a drug marketed by Bayer Healthcare Llc, Bayer Hlthcare, and Bayer Pharms, and is included in seven NDAs. Additional details are available on the MYCELEX profile page.

The generic ingredient in MYCELEX is clotrimazole. There are eleven drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the clotrimazole profile page.
Summary for 018183
Tradename:MYCELEX
Applicant:Bayer Healthcare Llc
Ingredient:clotrimazole
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 018183

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Expired US Patents for NDA 018183

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Healthcare Llc MYCELEX clotrimazole CREAM;TOPICAL 018183-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Bayer Healthcare Llc MYCELEX clotrimazole CREAM;TOPICAL 018183-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Bayer Healthcare Llc MYCELEX clotrimazole CREAM;TOPICAL 018183-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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