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FDA Approval Activities for this Drug…

Acyclovir Capsules, 200 mg, Ranbaxy Limited ANDA 74-975 9/30/98 9/30/98 9/25/02 Acyclovir Capsules, 200 mg. Genpharm, ANDA 74-977 4/13/98 3/19/99 Acyclovir Capsules USP, 200 mg Stason Industrial ANDA 75-090 1/26/99 1/26/99 Acyclovir Capsules, 200 mg. Chelsea , ANDA 75-101 4/15/98 3/22/99 Acyclovir Injection, 50 mg/mL, Gensia Sicor ANDA 75-627 3/28/01 3/30/01 Acyclovir Injection, 50 mg/mL (500 mg/10 mL & 1 g/20 mL vials) Abbott ANDA 75-114 7/26/99 7/29/99 Acyclovir Tablets, 400 mg & 800 mg. Copley Pharmaceutical, ANDA 75-021 3/18/98 3/19/99 Acyclovir Sodium Injection, 500 mg (base)/vial & 1 g (base)/vial Apothecon, ANDA 74-897 2/27/98 3/15/99 Acyclovir Sodium Injection, 10 mL and 20 mL vials, 50 mg (base)/mL Fujisawa USA ANDA 74-930 5/13/98 5/13/98 12/17/98 Acyclovir Sodium Injection, 10 mL and 20 mL vials, 50 mg (base)/mL Meridian Medical Technologies ANDA 75-065 2/25/99 3/4/99 Acyclovir Tablets, 400 mg and 800 mg, Mylan ANDA 75-211 9/28/98 9/28/98 8/6/03 Acyclovir Tablets, 400 mg and 800 mg, Ranbaxy Limited ANDA 74-980 9/30/98 9/30 Acyclovir Tablets, 400 mg and 800 mg, Genpharm, ANDA 74-976 4/13/98 1/8/02 1/8/02 1/8/02 Acyclovir Tablets USP,400 mg & 800 mg. Carlsbad Technology ANDA 75-382 4/30/99 Zovirax GlaxoSmithKline NDA 18-828/S-026 & S-027 4/15/03 Zovirax (Acylcovir Sodium) Cream, GlaxoSmithKline NDA 21-478 12/30/02 4/9/03 7/8/03 Zovirax (Acylcovir Sodium) Injection, GlaxoSmithKline NDA 18-603/S-023, S-024 & S-025 1/29/02 3/6/02 Zovirax (Acylcovir Sodium) for Injection, 10-mL and 20-mL vials Glaxo Wellcome NDA 18603/S-019 Zovirax (Acyclovir) Cream, GlaxoSmithKline ZOVIRAX (acyclovir sodium) for Injection, GlaxoSmithKline | ZOVIRAX (acyclovir) Capsules, GlaxoSmithKline | ZOVIRAX (acyclovir) Suspension, GlaxoSmithKline | ZOVIRAX (acyclovir) Tablets, GlaxoSmithKline | Acyclovir Oral Suspension, Hi-Tech Pharmacal, Approval

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