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