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Details for New Drug Application (NDA): 050744
NDA 050744 describes PERIOSTAT, which is a drug marketed by Collagenex and Galderma Labs Lp and is included in two NDAs. Additional details are available on the PERIOSTAT profile page.
The generic ingredient in PERIOSTAT is doxycycline hyclate. There are twenty-seven drug master file entries for this compound. Ninety-nine suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
The generic ingredient in PERIOSTAT is doxycycline hyclate. There are twenty-seven drug master file entries for this compound. Ninety-nine suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 050744
| Tradename: | PERIOSTAT |
| Applicant: | Collagenex |
| Ingredient: | doxycycline hyclate |
| Patents: | 0 |
| Therapeutic Class: | Antibacterials Dental and Oral Agents |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Sep 30, 1998 | TE: | RLD: | Yes | |||||
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