Reduces transmission Herpes Zoster Pediatric Patients Cold Sores (Herpes Labialis)…. ANDA 78518, held by Mylan Pharms Inc. Valacyclovir Hydrochloride.
As of Nov 15, 2026, ANDA 78518 (Valacyclovir Hydrochloride), held by Mylan Pharms Inc, was first approved by FDA on May 24, 2010, with 4 approved supplements and 0 published complete response letters.
Valacyclovir tablets are a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1–infected patients Reduction of transmission Herpes Zoster Pediatric Patients Cold Sores (Herpes Labialis) Chickenpox Limitations of Use The efficacy and safety of valacyclovir tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1–infected patients. 1.
| 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 |
| Oct 14, 2026 | Supplement 17Labeling · Standard review | Approved | None posted |
| May 11, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Mar 13, 2015 | Supplement 1Manufacturing | Approved | None posted |
| May 31, 2013 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 24, 2010 | Original application | Approved | None posted |
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
