FDA Approval Activities for this Drug…

Avelox (moxifloxacin) Tablets and Avelox (moxifloxacin) Injection, 400 mg & 400 mg/250 ml 0.8% saline respectively, Bayer NDA 21-085/S6, S7 & 21-277/S2 6/12/02 6/17/02 6/13/02 Avelox (moxifloxacin hydrochloride) Tablets and Avelox (moxifloxacin hydrochloride in NaCl) Injection, Bayer NDA 21-085/S19 21-277/S11 10/6/03 10/10/03 10/10/03 Avelox (moxifloxacin hydrochloride) Tablets and Avelox (moxifloxacin hydrochloride in NaCl) Injection, 400 mg, Bayer NDA 21-085/S-14, S-15 & S-17 & 21-277/S-6, S-7, & S-9 2/28/03 3/10/03 3/11/03 Avelox (moxifloxacin) Tablets and Avelox (moxifloxacin) Injection, 400 mg & 400 mg/250 ml 0.8% saline respectively, Bayer NDA 21-085/S-012 & 21-277/S-003 5/16/02 5/21/02 5/16/02 Avelox IV (Moxifloxacin Hydrochloride in Sodium Chloride) Injection, 400 mg/250 mL 0.8% saline, Bayer NDA 21-277/S1 5/22/02 6/3/02 Avelox IV (Moxifloxacin Hydrochloride in Sodium Chloride) Injection, 400 mg/250 mL, Bayer NDA 21-277 11/30/01 1/31/02 1/31/02 1/31/02 Avelox (moxifloxacin HCl) Tablet, 400mg, Bayer NDA 21-334 & 21-085/S10 4/27/01 10/17/01 10/17/01 10/17/01 Avelox Indications: uncomplicated skin and skin structure infections - This is not a new dosage form for a new route of administration. (NDA 21-085) for Avelox was approved 12/10/99 and the uncomplicated skin and skin structure infections indication was given AE action in the 12/10/99 letter. NDA 21-334 is a resubmission of this indication. Avelox (moxifloxacin HCl) Tablet, 400mg, Bayer NDA 21-085 12/10/99 12/28/99 12/28/99 7/18/01 Avelox Indications: are mild to moderate community acquired pneumonia, acute bacterial exacerbation of chronic bronchitis, and acute bacterial sinusitis. Vigamox (moxifloxacin hydrochloride) Ophthalmic Solution, 0.5%, Alcon, NDA 21-598/S1 & S5 10/3/03 10/10/03 10/10/03 Vigamox (moxifloxacin hydrochloride ophthalmic solution), 0.5%, Alcon, NDA 21-598 Avelox (moxifloxacin) Tablets and Injection, Bayer Pharmaceuticals Vigamox (moxifloxacin hydrochloride) Ophthalmic Solution, Alcon, Inc. AVELOX (moxifloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corporation AVELOX I.V. (moxifloxacin hydrochloride in sodium chloride injection), Bayer Pharmaceuticals Corporation Vigamox (moxifloxacin HCl ophthalmic solution), Alcon Inc. AVELOX (moxifloxacin hydrochloride in NaCl injection), Bayer Pharmaceuticals, Labeling Revision AVELOX (moxifloxacin hydrochloride) Tablets, Bayer Pharmaceuticals, Labeling Revision

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