ANDA 90216, held by Chartwell Rx. Valacyclovir Hydrochloride.
As of Nov 15, 2026, ANDA 90216 (Valacyclovir Hydrochloride), held by Chartwell Rx, was first approved by FDA on May 24, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 24, 2010 | Original application | Approved | None posted |
| Valacyclovir HydrochlorideEQ 500MG BASE · tablet;oral | Valacyclovir Hydrochloride | Rx |
| Valacyclovir HydrochlorideEQ 1GM BASE · tablet;oral | Valacyclovir Hydrochloride | Rx |
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
