What's New on the FDA Drugs Site
September 16, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages: New and Updated
- Clonidine HCL Injection (Duraclon) (Currently in Shortage)
- Piperacillin and Tazobactam (Zosyn) Injection (Currently in Shortage)
- Rifampin for Injection (Currently in Shortage)
- Guidance for Industry:
- National Drug Code Directory
New and Generic Drug Approvals
September 15, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Adenosine | adenosine | Injectable; Injection | Emcure Pharms Ltd | Approval |
| Aminosyn Ii 10% In Plastic Container | amino acids | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Amoxicillin | amoxicillin | Suspension;Oral | Aurobindo Pharma Ltd | Approval |
| Budesonide | budesonide | Solution;Topical Foam | Salix Pharms | Tentative Approval |
| Centany | mupirocin | Ointment;Topical | Perrigo New York | 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 |
| Clopidogrel | clopidogrel | Tablet;Oral | Sciegen Pharms Inc | Approval |
| Glipizide | glipizide | Tablet, Extended Release;Oral | Zydus Pharms Usa Inc | Tentative Approval |
| Membraneblue | trypan blue | Solution;Ophthalmic | Dorc | Labeling Revision |
| Methylin | methylphenidate hydrochloride | Solution;Oral | Mallinckrodt | Manufacturing Change or Addition |
| Methylin | methylphenidate hydrochloride | Tablet, Chewable;Oral | Mallinckrodt | Manufacturing Change or Addition |
| Setlakin | ethinyl estradiol; levonorgestrel | Tablet;Oral | Novast Labs Ltd | Approval |
| Travasol 10% In Plastic Container | amino acids | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Travasol 5.5% In Plastic Container | amino acids | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Travasol 8.5% In Plastic Container | amino acids | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
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