Prevents malaria. NDA 205931, held by Chartwell Rx. Doxycycline Hyclate.
As of Nov 14, 2026, NDA 205931 (Acticlate), held by Chartwell Rx, was first approved by FDA on Jul 25, 2014, with 5 approved supplements and 0 published complete response letters.
Doxycycline hyclate tablets and doxycycline hyclate capsules are tetracycline class drugs indicated for: Rickettsial infections Sexually transmitted infections Respiratory tract infections Specific bacterial infections Ophthalmic infections Anthrax, including inhalational anthrax (post-exposure) Alternative treatment for selected infections when penicillin is contraindicated Adjunctive therapy for acute intestinal amebiasis and severe acne Prophylaxis of malaria To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or stron…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 25, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| ActiclateEQ 75MG BASE · tablet;oral | Doxycycline Hyclate | RxReference drug |
| ActiclateEQ 150MG BASE · tablet;oral | Doxycycline Hyclate | RxReference drug |
| Mar 31, 2025 | Supplement 6Labeling · Standard review | Approved | |
| Mar 4, 2020 | Supplement 5Labeling · Standard review | Approved | |
| Dec 26, 2019 | Supplement 4Labeling · Standard review | Approved | |
| Nov 15, 2017 | Supplement 3Labeling · Standard review | Approved | |
| Apr 26, 2016 | Supplement 2Labeling · Standard review | Approved | |
| Jul 25, 2014 | 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
