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… 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 | Acyclovir Capsules, Apotex Corp., Approval | ZOVIRAX (acyclovir) Capsules, GlaxoSmithKline, Labeling Revision | ZOVIRAX (acyclovir) Tablets, GlaxoSmithKline, Labeling Revision | ZOVIRAX (acyclovir) Suspension, GlaxoSmithKline, Labeling Revision | Acyclovir and Hydrocortisone Topical Cream, Medivir, Labeling Revision | Acyclovir, acyclovir, Ointment; Topical, Mylan Pharms Inc, Approval | Sitavig, acyclovir, Tablet; Buccal, Bioalliance Pharma Sa, 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 © 2013 Betterchem.com