Details for New Drug Application (NDA): 018052
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NDA 018052 describes GYNE-LOTRIMIN, which is a drug marketed by Bayer Healthcare Llc and is included in six NDAs. Additional details are available on the GYNE-LOTRIMIN profile page.
The generic ingredient in GYNE-LOTRIMIN is clotrimazole. There are eleven drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the clotrimazole profile page.
The generic ingredient in GYNE-LOTRIMIN is clotrimazole. There are eleven drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the clotrimazole profile page.
Summary for 018052
| Tradename: | GYNE-LOTRIMIN |
| Applicant: | Bayer Healthcare Llc |
| Ingredient: | clotrimazole |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 018052
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;VAGINAL | Strength | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 30, 1990 | TE: | RLD: | Yes | |||||
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