Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… Valtrex (valacyclovir hydrochloride) Capsules, GlaxoSmithKline NDA 20-550/S21 8/8/03 8/15/03 Valtrex (valacyclovir hydrochloride) Caplets, 500 mg, GlaxoSmithKline NDA 20-550/S19 8/29/03 9/09/03 8/29/03 Valtrex Indication: Reduction of the risk of transmission of genital herpes during suppressive therapy of the source partner in a heterosexual couple. Valtrex (valacyclovir hydrochloride), GlaxoSmithKline NDA 20-550/S10, S13 6/25/01 4/25/03 Valtrex (valacyclovir hydrochloride), GlaxoSmithKline NDA 20-550/S16 9/9/02 9/11/02 Valtrex (valacyclovir hydrochloride), GlaxoSmithKline NDA 20-550S12 7/13/01 11/6/01 11/6/01 Valtrex (valacyclovir hydrochloride) 500 mg and 1 gram Caplets. GlaxoSmithKline NDA 20-550/S-005 4/1/03 4/18/03 4/18/03 Valtrex (valacyclovir hydrochloride) Caplets, 500 mg, GlaxoSmithKline NDA 20-550   For the latest approval information, locate this drug using this index.