NDA 209844, held by Chartwell Pharma. Doxycycline Hyclate.
As of Nov 13, 2026, NDA 209844 (Lymepak), held by Chartwell Pharma, was first approved by FDA on Jun 15, 2018, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 15, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| LymepakEQ 100MG BASE · tablet;oral | Doxycycline Hyclate | DiscontinuedReference drug |
| Mar 31, 2025 | Supplement 2Labeling · Standard review | Approved | |
| Jan 24, 2019 | Supplement 1Labeling · Standard review | Approved | |
| Jun 15, 2018 | Original applicationNew formulation or manufacturer · 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
