NDA 50783, held by Galderma Labs LP. Doxycycline Hyclate.
As of Nov 13, 2026, NDA 50783 (Periostat), held by Galderma Labs LP, was first approved by FDA on Feb 2, 2001, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 2, 2001 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| PeriostatEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Doxycycline Hyclate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 1, 2025 | Supplement 5Labeling · Standard review | Approved | |
| Mar 31, 2004 | Supplement 2Labeling · Standard review | Approved | |
| Jul 19, 2001 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 2, 2001 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
