New and Generic Drug Approvals
August 29, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Citanest Forte Dental | epinephrine bitartrate; prilocaine hydrochloride | Injectable;Injection | Dentsply Pharm | Manufacturing Change or Addition |
| Cleocin | clindamycin phosphate | Swab;Topical | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Cleocin T | clindamycin phosphate | Solution;Topical | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Clinimix 2.75/10 Sulfite Free In Dextrose 10% In Plastic Container | amino acids; dextrose | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix 2.75/25 Sulfite Free In Dextrose 25% In Plastic Container | amino acids; dextrose | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix 2.75/5 Sulfite Free In Dextrose 5% In Plastic Container | amino acids; dextrose | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix 4.25/10 Sulfite Free In Dextrose 10% In Plastic Container | amino acids; dextrose | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix 4.25/20 Sulfite Free In Dextrose 20% In Plastic Container | amino acids; dextrose | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix 4.25/25 Sulfite Free In Dextrose 25% In Plastic Container | amino acids; dextrose | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix 4.25/5 Sulfite Free In Dextrose 5% In Plastic Container | amino acids; dextrose | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix 5/10 Sulfite Free In Dextrose 10% In Plastic Container | amino acids; dextrose | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix 5/15 Sulfite Free In Dextrose 15% In Plastic Container | amino acids; dextrose | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix 5/20 Sulfite Free In Dextrose 20% In Plastic Container | amino acids; dextrose | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix 5/25 Sulfite Free In Dextrose 25% In Plastic Container | amino acids; dextrose | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix 5/35 Sulfite Free In Dextrose 35% In Plastic Container | amino acids; dextrose | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 2.75/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 2.75/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 2.75/5 Sulfite-Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 4.25/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 4.25/20 Sulfite-Free W/ Elect In Dextrose 20% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 4.25/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 4.25/5 Sulfite-Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 5/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 5/15 Sulfite-Free W/ Elect In Dextrose 15% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 5/20 Sulfite-Free W/ Elect In 20% Dextrose W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 5/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 5/35 Sulfite-Free W/ Elect In Dextrose 35% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Dextrose 2.5% and Sodium Chloride 0.45% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Dostinex | cabergoline | Tablet;Oral | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Fentora | fentanyl citrate | Tablet;Buccal, Sublingual | Cephalon | Manufacturing Change or Addition |
| Hexalen | altretamine | Capsule;Oral | Eisai Inc | Manufacturing Change or Addition |
| Omnitrope | somatropin recombinant | Injectable;Injection | Sandoz | Labeling Revision |
| Prosol 20% Sulfite Free In Plastic Container | amino acids | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Riomet | metformin hydrochloride | Solution;Oral | Ranbaxy | Manufacturing Change or Addition |
| Sterile Water For Injection In Plastic Container | sterile water for injection | Liquid;N/A | B Braun | Manufacturing Change or Addition |
| Vivitrol | naltrexone | For Suspension, Extended Release;Intramuscular | Alkermes | Manufacturing Change or Addition |
| Zanaflex | tizanidine hydrochloride | Capsule;Oral | Acorda | Manufacturing Change or Addition |
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