Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com