What's New on the FDA Drugs Site
April 15, 2013
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- National Drug Code Directory (updated)
New and Generic Drug Approvals
April 12, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Colgate Total | sodium fluoride; triclosan | Paste; Dental | Colgate Palmolive | Manufacturing Change or Addition |
| Docetaxel | docetaxel | Injectable; Injection | Actavis Inc | Approval |
| Ortho Evra | ethinyl estradiol; norelgestromin | Film, Extended Release; Transdermal | Janssen Pharms | Manufacturing Change or Addition |
| Oxycodone and Acetaminophen | acetaminophen; oxycodone hydrochloride | Tablet; Oral | Actavis Elizabeth | Approval |
| Perjeta | pertuzumab | Vial; Single-Use | Genentech | Efficacy Supplement with Clinical Data to Support |
| Rocephin | ceftriaxone sodium | Injectable; Im-Iv | Hoffmann La Roche | Labeling Revision |
| Rocephin | ceftriaxone sodium | Injectable; Injection | Hoffmann La Roche | Labeling Revision |
| Rocephin Kit | ceftriaxone sodium; lidocaine | Injectable; Injection | Hoffmann La Roche | Labeling Revision |
| Sitavig | acyclovir | Tablet; Buccal | Bioalliance Pharma Sa | Approval |
| Vascepa | icosapent ethyl | Capsule; Oral | Amarin Pharma Inc | Manufacturing Change or Addition |
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