NDA 204914, held by Mylan Labs. Lamivudine; Zidovudine.
As of Nov 15, 2026, NDA 204914 (Lamivudine; Zidovudine), held by Mylan Labs, was not approved, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 4, 2014 | Original applicationNew formulation or manufacturer · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lamivudine; Zidovudine30MG; 60MG · tablet; oral suspension | Lamivudine; Zidovudine | None (tentative approval) |
| May 14, 2015 | Supplement 1Manufacturing | Approved | None posted |
| Feb 4, 2014 | Original applicationNew formulation or manufacturer · Standard review | Tentative approval |
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
