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Details for New Drug Application (NDA): 019568
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NDA 019568 describes DERMATOP, which is a drug marketed by Valeant Pharms North and Valeant Bermuda and is included in two NDAs. Additional details are available on the DERMATOP profile page.
The generic ingredient in DERMATOP is prednicarbate. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the prednicarbate profile page.
The generic ingredient in DERMATOP is prednicarbate. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the prednicarbate profile page.
Summary for 019568
| Tradename: | DERMATOP |
| Applicant: | Valeant Pharms North |
| Ingredient: | prednicarbate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | OINTMENT;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Sep 23, 1991 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 019568
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Valeant Pharms North | DERMATOP | prednicarbate | OINTMENT;TOPICAL | 019568-001 | Sep 23, 1991 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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