Details for New Drug Application (NDA): 050783
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NDA 050783 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-eight drug master file entries for this compound. Seventy-four 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-eight drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 050783
| Tradename: | PERIOSTAT |
| Applicant: | Galderma Labs Lp |
| Ingredient: | doxycycline hyclate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Feb 2, 2001 | TE: | RLD: | Yes | |||||
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