FDA Approves ANDA077655 for VALACYCLOVIR HYDROCHLORIDE Tablets

The U.S. Food and Drug Administration (FDA) has granted approval for ANDA077655, submitted by Teva Pharm, covering two oral tablet products of VALACYCLOVIR HYDROCHLORIDE. Product 001 is a 500 mg equivalent tablet and product 002 is a 1 g equivalent tablet. Both products are listed with a marketing status of "Discontinued" and are not designated as reference drugs or reference standards. The approval timeline includes an original (ORIG) submission (submission number 1) approved on May 24, 2010. Two supplemental (SUPPL) labeling submissions were also approved: submission number 7 on October 30, 2012 and submission number 9 on November 17, 2020, both classified under the LABELING category. These approvals confirm that the generic valacyclovir hydrochloride tablets meet FDA requirements for safety, efficacy, and labeling, despite their discontinued marketing status.