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FDA Approval Activities for this Drug…
Ciloxan (Ciprofloxacin HCl ophthalmic ointment), 0.3% Alcon NDA 20-369/S6 & S7 8/19/03 8/28/03 8/28/03 Ciloxan/ciprofloxacin HCl ophthalmic ointment Alcon NDA 20-369 Cipro HC Otic/Ciprofloxacin Hydrochloride & Hydrocortisone Otic Suspension, Bayer NDA 20-805 2/10/98 1/7/99 1/7/99 1/7/99 Cipro XR (ciprofloxacin) Extended-Release Tablets, 1g, Bayer NDA 21-554 8/27/03 09/09/03 09/09/03 Cipro XR (ciprofloxacin) Extended-Release Tablets, 500 mg, Bayer NDA 21-473 12/13/02 1/30/03 12/16/02 10/9/03 Cipro (ciprofloxacin hydrochloride) Tablets, Bayer NDA 19-537/S-043 12/13/02 1/29/03 Cipro (Ciprofloxacin Hydrochloride) Tablets & Cipro (ciprofloxacin) Suspension, 5% and 10%, Bayer , Pharmaceutical Division NDA 19-537/S41 & 20-780/S11 4/17/02 4/22/02 4/18/02 Cipro (Ciprofloxacin) IV Solution, Bayer , Pharmaceutical Division NDA 19-847/S026, 19-857/S028 & 19-858/S022 4/17/02 4/22/02 4/18/02 Cipro (Ciprofloxacin Hydrochloride) Tablets, IV Solution, IV in 5% Dextrose, IV in 0.9% Saline, & Suspension, Bayer , Pharmaceutical Division NDA 19-537/S038, 19-847/S024, 19-857/S027, 19-858/S021, 20-780/S008 8/30/00 9/7/00 9/7/00 10/16/01 CIPRODEX (ciprofloxacin 0.3% and dexamethasone 0.1% ) Sterile Otic Suspension, Alcon Research, Ltd. NDA 21-537 7/18/03 7/28/03 Ciprofloxacin Ophthalmic Solution USP, 0.3%, Novex Pharma ANDA 75-928 2/4/02 4/10/03 Ciprofloxacin Tablets USP, 250 mg, 500, and 750 mg, Technilab Pharma, ANDA 76-138 9/11/02 Ciprofloxacin Tablets USP, 250 mg, 500, and 750 mg, Teva USA ANDA 76-136 12/26/01 4/16/03 Ciprofloxacin Tablets USP, 250 mg, 500, and 750 mg, Carlsbad Technology, ANDA 76-126 8/14/02 Ciprofloxacin Tablets USP, 100 mg, 250 mg, 500, and 750 mg, Ivax ANDA 76-089 9/25/03 Ciprofloxacin Tablets USP, 100 mg, 250 mg, 500, and 750 mg, 5/30/01 Geneva ANDA 75-939 5/30/01 6/5/01 Ciprofloxacin Tablets USP, 100 mg, 250 mg, 500, and 750 mg, 8/31/01 Genpharm ANDA 75-817 8/31/01 4/15/03 Ciprofloxacin Tablets USP, 250 mg, 500, and 750 mg, 3/30/01 Ranbaxy ANDA 75-747 3/30/01 3/30/01 Ciprofloxacin Tablets USP, 250, 500 & 750 mg, 7/18/01 Mylan ANDA 75-685 7/18/01 Ciprofloxacin Tablets USP,750 mg, 3/30/00 Mylan ANDA 75-685 3/30/00 4/4/00 Ciprofloxacin Tablets USP, 100 mg, 250 mg, 500, and 750 mg, 8/22/02 Dr. Reddy's Ltd. ANDA 75-593 8/22/02 Ciprofloxacin Tablets USP, 250 mg, 500 mg, 500 mg, and 750 mg, 3/24/99 Novopharm ANDA 74-876 CIPROFLOXACIN For Suspension; 250MG/5ML CIPRO BAYER 020780 CIPROFLOXACIN For Suspension; 500MG/5ML CIPRO BAYER 019847 CIPROFLOXACIN Injection 10MG/ML CIPRO BAYER 019857 CIPROFLOXACIN Injection 200MG/100ML CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER BAYER 020369 CIPROFLOXACIN HYDROCHLORIDE Ointment; Ophthalmic 0.3% BASE CILOXAN Alcon 019992 CIPROFLOXACIN HYDROCHLORIDE Solution/Drops; Ophthalmic 0.3% BASE CILOXAN Alcon 019537 CIPROFLOXACIN HYDROCHLORIDE Tablet; 100MG BASE CIPRO BAYER 019537 CIPROFLOXACIN HYDROCHLORIDE Tablet; 250MG BASE CIPRO BAYER 019537 CIPROFLOXACIN HYDROCHLORIDE Tablet; 500MG BASE CIPRO BAYER 019537 CIPROFLOXACIN HYDROCHLORIDE Tablet; 750MG BASE CIPRO BAYER 020805 CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE Suspension/Drops; Otic 0.2% BASE;1% CIPRO HC Alcon 021473 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE Tablet, Extended Release; 212.6MG;EQ 287.5MG BASE CIPRO XR BAYER 021473 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE Tablet; 425.2MG;EQ 574.9MG BASE CIPRO XR BAYER 021537 CIPROFLOXACIN; DEXAMETHASONE Suspension/Drops; Otic 0.3%;0.1% CIPRODEX Alcon Ciprofloxacin Injection USP, American Pharmaceutical, Ciprofloxacin Tablets USP, Hikma Pharmaceuticals, Cipro, Bayer Corporation Cipro (Ciprofloxacin Hydrochloride) Tablets, IV Solution, IV in 5% Dextrose & Oral Suspension, Bayer Pharmaceuticals Ciloxan (ciprofloxacin hydrochloride ophthalmic ointment), Alcon Laboratories, Labeling Revision Cipro (Ciprofloxacin Hydrochloride) Tablets, Bayer Corporation, Labeling Revision Cipro (Ciprofloxacin) Extended Release Tablets, Bayer Corporation, Labeling Revision Cipro (Ciprofloxacin) IV 0.2% Solution, Bayer Corporation, Labeling Revision Cipro (Ciprofloxacin) IV 1% Solution, Bayer Corporation, Labeling Revision Cipro (Ciprofloxacin) Oral Suspension, Bayer Corporation, Labeling Revision Ciloxan (ciprofloxacin hydrochloride ophthalmic solution), Alcon, Inc., Labeling Revision Ciprofloxacin Tablets, Unique Pharmaceutical, Approval | Ciprofloxacin Injection, Bedford Labs, Tentative Approval | Ciprofloxacin Tablets, Apotex Inc., Approval | Cipro (ciprofloxacin hydrochloride) Tablets, Bayer Pharma, Accelerated Approval | Cipro IV (ciprofloxacin) 1% Solution Vials, Bayer Pharma, Accelerated Approval | Cipro IV (ciprofloxacin) 0.2% Solution in 5% Dextrose, Bayer Pharma, Accelerated Approval | Cipro (ciprofloxacin) Oral Suspension, Bayer Pharma, Accelerated Approval | Ciprofloxacin Ophthalmic Solution, Hi-Tech Pharmacal, Approval | Ciprofloxacin Tablets, Cobalt Pharma, Supplement | Ciprofloxacin Tablets, Taro Pharma, Supplement | Ciprofloxacin Injection, Bedford Labs, Tentative Approval | Ciprofloxacin Tablets, Sandoz Inc., Supplement | Cipro (ciprofloxacin hydrochloride) Tablets, Bayer Pharma, Labeling Revision | Cipro (ciprofloxacin) Oral Suspension, Bayer Pharma, Labeling Revision | Cipro (ciprofloxacin) IV Solution, Bayer Pharma, Labeling Revision | Cipro (ciprofloxacin) IV Solution in/Dextrose, Bayer Pharma, Labeling Revision | CIPRO XR (ciprofloxacin) extended-release tablets, Bayer Pharma, Labeling Revision | Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets, Depomed, Approval | Ciprofloxacin Tablets, Pliva, Approval | Ciloxan (ciprofloxacin HCl ophthalmic solution), Alcon, Inc., Labeling Revision | Ciprofloxacin Injection, Hospira Inc., Tentative Approval | CIPRO (ciprofloxacin hydrochloride) Tablets, Bayer Pharma, Labeling Revision | CIPRO (ciprofloxacin) Oral Suspension, Bayer Pharma, Labeling Revision | CIPRO (ciprofloxacin) IV Solution, Bayer Pharma, Labeling Revision | CIPRO (ciprofloxacin) IV Solution, Bayer Pharma, Labeling Revision | CIPRO XR (ciprofloxacin) Extended-Release Tablets, Bayer Pharma, Labeling Revision | Proquin XR (ciprofloxacin HCl extended-release) Tablets, Esprit Pharma, Expiration Date Change | Ciprofloxacin Injection, Abraxis, Approval | Ciprofloxacin Injection, Bedford, Approval | Ciprofloxacin Injection, Bedford, Approval | Ciprofloxacin Injection, Hospira, Approval | Ciprofloxacin Injection, SICOR, Approval | Ciprofloxacin and Dextrose (5%) Injection, Hospira, Tentative Approval | Ciprofloxacin Ophthalmic Solution, Nexus Pharma, Approval | Ciprofloxacin Extended-release Tablets, Mylan Pharma, Approval | Ciprofloxacin Extended-Release Tablets, Dr. Reddy’s Labs, Approval | Ciprofloxacin Tablets, Aurobindo Pharma, Approval | CIPRO (ciprofloxacin hydrochloride) Tablets, Bayer Pharma, Labeling Revision | CIPRO IV (ciprofloxacin) Solution, Bayer Pharma, Labeling Revision | CIPRO IV (ciprofloxacin) Solution in Dextrose, Bayer Pharma, Labeling Revision | CIPRO (ciprofloxacin) Oral Suspension, Bayer Pharma, Labeling Revision | CIPRO XR (ciprofloxacin) Extended-Release Tablets, Bayer Pharma, Labeling Revision | Ciprofloxacin Tablets, Genpharm Inc., Control Supplement | Proquin XR (ciprofloxacin hydrochloride) Tablets, Esprit Pharma, Labeling Revision | Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets, Depomed Inc., Labeling Revision | Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets, Depomed Inc., Labeling Revision | Ciprofloxacin Extended-release Tablets, Dr. Reddy’s Labs, Approval | Ciprofloxacin Extended-release Tablets, Anchen Pharma, Approval | Ciprofloxacin Extended-release Tablets, Sandoz Inc., Approval | Ciprofloxacin Ophthalmic Solution, PharmaForce, Inc., Approval | CIPRO XR (ciprofloxacin extended-release) Tablets, Bayer Pharma, Labeling Revision | CIPRO (ciprofloxacin hydrochloride) Tablets, Bayer Pharma, Labeling Revision | CIPRO (ciprofloxacin hydrochloride) Oral Suspension, Bayer Pharma, Labeling Revision | CIPRO (ciprofloxacin hydrochloride) Intravenous Solution, Bayer Pharma, Labeling Revision | Ciprofloxacin and Dextrose (5%) Injection, Claris Lifesciences, Tentative Approval | Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Baxter Healthcare, Inc., Approval | Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Bedford Inc., Approval | Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Claris Lifesciences Ltd., Approval | Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Hospira Inc., Approval | Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Sagent Pharmaceuticals, Approval | Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Teva Parenteral Medicines, Inc, Approval | Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Hikma Farmaceutica, Approval | Ciprofloxacin Injection, Claris Lifesciences, Approval | Ciprofloxacin Ophthalmic Solution, FDC Ltd., Approval
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