ANDA 78070, held by Pharmobedient. Valacyclovir Hydrochloride.
As of Nov 15, 2026, ANDA 78070 (Valacyclovir Hydrochloride), held by Pharmobedient, 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 | Discontinued |
| Valacyclovir HydrochlorideEQ 1GM BASE · tablet;oral | Valacyclovir Hydrochloride | Discontinued |
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
