Regulatory UpdatesSep 16, 2026•1 min read

FDA Approves ANDA203834 for Acyclovir Oral Tablets

By the PharmaCountry team

The FDA has approved ANDA203834 for prescription oral acyclovir tablets (400 mg and 800 mg) manufactured by Camber Pharmaceuticals and sponsored by Hetero Labs.

The U.S. Food and Drug Administration (FDA) announced approval of Abbreviated New Drug Application (ANDA) 203834 for the antiviral drug acyclovir. The approved products are oral tablets available in 400 mg and 800 mg strengths. Both are prescription‑only and are marketed under the brand name Acyclovir. The tablets are identified by NDC codes 31722‑777‑01, 31722‑777‑05 (400 mg) and 31722‑778‑01, 31722‑778‑05 (800 mg). Camber Pharmaceuticals, Inc. is listed as the manufacturer, while Hetero Labs Ltd. is the sponsor of the application. The submission was originally filed as an original (ORIG) submission and received an approved (AP) status on October 29, 2013. Acyclovir is classified as a DNA polymerase inhibitor targeting herpes simplex and herpes zoster viruses.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#acyclovir #Oral Tablet #ANDA #FDA approval #antiviral #prescription drug