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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 | Valtrex (valacyclovir hydrochloride) Caplets, GlaxoSmithKline, Labeling Revision | Valacyclovir Hydrochloride Tablets, Watson Labs, Tentative Approval | Valacyclovir Hydrochloride Tablets, Ranbaxy Labs, Approval | Valacyclovir Hydrochloride Tablets, Sandoz Inc., Tentative Approval | Valacyclovir Hydrochloride Tablets, Teva Pharma, Tentative Approval | Valtrex (valacyclovir hydrochloride) Caplets, GlaxoSmithKline, Labeling Revision | Valacyclovir Hydrochloride Tablets, Matrix Labs, Tentative Approval | Valtrex (valacyclovir hydrochloride) Tablets, GlaxoSmithKline, Patient Population Altered | Valacyclovir Hydrochloride Tablets, Dr. Reddy's Laboratories Ltd., Tentative Approval | Valtrex (valacyclovir hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision | Valacyclovir Hydrochloride Tablets, Aurobindo Pharma USA, Inc., Approval | Valacyclovir Hydrochloride Tablets, Dr. Reddy's Laboratories, Ltd., Approval | Valacyclovir Hydrochloride Tablets, Mylan Pharmaceuticals Inc., Approval | Valacyclovir Hydrochloride Tablets, Matrix Laboratories Ltd., Approval | Valacyclovir Hydrochloride Tablets, Roxane Laboratories, Inc., Approval | Valacyclovir Hydrochloride Tablets, Sandoz Inc., Approval | Valacyclovir Hydrochloride Tablets, Teva Pharmaceuticals USA, Approval | Valacyclovir Hydrochloride Tablets, Watson Laboratories, Inc., Approval | Valacyclovir Hydrochloride Tablets, Actavis Pharma, Approval
  
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