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FDA approval activities for this prescription 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, please locate this API using this index.

 
                                                                                  


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