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FDA Approval Activities for this Drug…
Diflucan (Fluconazole) Tablets, Injection & Powder, 150 mg, Pfizer, NDA 19-949/S33, 19-950/S33 & 20-090/S15 Fluconazole Injection, 200mg/100mL & 400mg/200mL, (Tentatively Approved 4/15/03) American Pharmaceutical Partners, ANDA 76-145 4/15/03 Fluconazole Injection, 2 mg/mL, Bedford ANDA 76-087 7/17/03 Fluconazole Injection, 2mg/mL, (IN 5% DEXTROSE INJECTION), Abbott ANDA 76-304 6/18/03 Fluconazole Injection, 2mg/mL, (IN 0.9% SODIUM CHLORIDE INJECTION), Abbott ANDA 76-303 6/18/03 Fluconazole Suspension, 10 mg/mL and 40 mg/mL, Ranbaxy ANDA 76-332 7/11/03 Fluconazole Suspension, 10 mg/mL and 40 mg/mL, (Tentatively Approved 4/18/03) Roxane, ANDA 76-246 4/18/03 Fluconazole Tablets, 50 mg, 100 mg, 150 mg, & 200 mg, (Tentatively Approved) Gedeon Richter ANDA 76-432 9/25/03 Fluconazole Tablets, 50 mg, 100 mg, 150 mg, & 200 mg, (Tentatively Approved) Pliva, ANDA 76-424 5/9/03 Fluconazole Tablets, 50 mg, 100 mg, 150 mg, & 200 mg, (Tentatively Approved) Ranbaxy ANDA 76-386 5/1/03 Fluconazole Tablets, 50 mg, 100 mg, 150 mg, & 200 mg, (Tentatively Approved 2/11/03) Roxane, ANDA 76-213 2/11/03 Fluconazole Tablets, 50 mg, 100 mg, 150 mg, & 200 mg, (Tentatively Approved) Geneva ANDA 76-086 6/10/03 Fluconazole Tablets, 50 mg, 100 mg, 150 mg, & 200 mg, (Tentatively Approved 4/10/03) Genpharm ANDA 76-042 4/10/03 Fluconazole Tablets, 50 mg, 100 mg, 150 mg, & 200 mg. ( 6/18/99) Novopharm Limited ANDA 74-681 Fluconazole Injection, Faulding Pharmaceutical, Fluconazole Injection, Faulding Pharmaceutical, Fluconazole Tablets, Ivax Pharmaceuticals Diflucan (Fluconazole) Tablets, Injection & Oral Powder, Pfizer, Inc. Fluconazole Injection, Baxter Healthcare Corporation, Fluconazole Tablets, Dr. Reddy's Laboratories Fluconazole Tablets, Apotex Corp., Fluconazole Injection, American Pharmaceutical, Approval | Fluconazole Injection, Baxter Healthcare, Approval | Fluconazole Injection, Bedford Laboratories, Approval | Fluconazole Injection, Hospira Inc., Approval | Fluconazole Injection, Hospira Inc., Approval | Fluconazole Injection, Mayne Pharma, Approval | Fluconazole Injection, Sicor Pharmaceuticals, Approval | Fluconazole Oral Suspension, Ranbaxy Laboratories, Approval | Fluconazole Oral Suspension, Roxane Laboratories, Approval | Fluconazole Tablets, Apotex Inc., Approval | Fluconazole Tablets, Dr. Reddy's Laboratories, Approval | Fluconazole Tablets, Gedeon Richter, Inc., Approval | Fluconazole Tablets, Genpharm Inc., Approval | Fluconazole Tablets, Ivax Pharmaceuticals, Approval | Fluconazole Tablets, Mylan Pharmaceuticals, Approval | Fluconazole Tablets, Novopharm Limited, Approval | Fluconazole Tablets, Pliva, Inc., Approval | Fluconazole Tablets, Ranbaxy Laboratories, Approval | Fluconazole Tablets, Roxane Laboratories, Approval | Fluconazole Tablets, Sandoz, Inc., Approval | Fluconazole Tablets, Taro Pharmaceutical, Approval | Fluconazole Tablets, Teva Pharmaceuticals, Approval | | Diflucan (fluconazole) Tablets, Pfizer, Inc., Labeling Revision | Diflucan (fluconazole) Injection, Pfizer, Inc., Labeling Revision | Diflucan (fluconazole) Powder, Pfizer, Inc., Labeling Revision | Fluconazole Injection, Sicor Pharma, Approval | Fluconazole (in Dextrose) Injection, Apotex, Approval | Fluconazole (in Sodium Chloride) Injection, Apotex, Approval | Fluconazole Injection, Hikma Farmaceutica, Approval | Fluconazole Tablets, Unique Pharmaceutical Laboratories, Approval | Fluconazole Tablets, Glenmark Pharma, Approval | Fluconazole Oral Suspension, Ivax Pharma, Approval | Fluconazole Tablets USP, Taro Pharma, Control Supplement | Fluconazole Tablets, Teva Pharma, Control Supplement | Fluconazole in Sodium Chloride 0.9% in Plastic Container (fluconazole) Injection, Bedford Laboratories, Approval
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