|
|
|
 |
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 | AVELOX (moxifloxacin hydrochloride) Tablets, Bayer Corporation, New or Modified Indication | AVELOX (moxifloxacin hydrochloride in NaCl) Injection, Bayer Corporation, New or Modified Indication | Moxifloxacin Hydrochloride Tablets, Teva Pharma, Tentative Approval | Avelox (moxifloxacin hydrochloride) Tablets, Bayer Pharma, Labeling Revision | Avelox (moxifloxacin hydrochloride in NaC1) I.V. Injection, Bayer Pharma, Labeling Revision | Avelox (moxifloxacin hydrochloride) Tablets, Bayer Pharma, Labeling Revision | Avelox (moxifloxacin hydrochloride in NaCl) I.V., Bayer Pharma, Labeling Revision | Moxifloxacin Hydrochloride Tablets, Dr. Reddy’s Labs, Tentative Approval | Avelox (moxifloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision | Avelox In Sodium Chloride 0.8% In Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer Pharmaceuticals Corp., Labeling Revision | Avelox (moxifloxacin hydrochloride) Tablets, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision | Avelox in Sodium Chloride 0.8% in Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision | AVELOX (moxifloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corporation Labeling Revision | AVELOX (moxifloxacin hydrochloride in NaCl injection) I.V, Bayer Pharmaceuticals Corporation Labeling Revision | Moxifloxacin Hydrochloride Ophthalmic Solution, Teva Parenteral Medicines, Inc., Tentative Approval | AVELOX (moxifloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision | AVELOX in Sodium Chloride 0.8% in Plastic Container (moxifloxacin hydrochloride) I.V. Injection , Bayer Pharmaceuticals Corp., Labeling Revision | Avelox (moxifloxacin hydrochloride) Tablets, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision | | Aveloxin Sodium Chloride 0.8% in Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision | Avelox (moxifloxacin hydrochloride) Tablets, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision | Avelox in Sodium Chloride 0.8% in Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision | Avelox (moxifloxacin hydrochloride) Tablets, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision | Avelox in Sodium Chloride 0.8% in Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision | Moxeza (moxifloxacin hydrochloride) Ophthalmic Solution, Alcon Research Ltd., Approval | Avelox (moxifloxacin hydrochloride) Tablets, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision | Avelox in Sodium Chloride 0.8% in Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision | Avelox (moxifloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision | Avelox in Sodium Chloride 0.8% in Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer Pharmaceuticals Corp., Labeling Revision | Vigamox (moxifloxacin hydrochloride) Ophthalmic Solution, Alcon Research, Ltd., Labeling Revision | Moxeza (moxifloxacin hydrochloride) Ophthalmic Solution, Alcon Pharmaceuticals, Ltd., Labeling Revision | Avelox (moxifloxacin hydrochloride) Tablets, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision | Avelox in Sodium Chloride 0.8% in Plastic Container (moxifloxacin hydrochloride) IV Injection, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision
  
|