What's New on the FDA Drugs Site
April 17, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
New and Generic Drug Approvals
April 16, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Allegra Allergy | fexofenadine hydrochloride | Tablet;Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Allegra Hives | fexofenadine hydrochloride | Tablet;Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Avinza | morphine sulfate | Capsule, Extended Release;Oral | King Pfizer | Labeling Revision |
| Butrans | buprenorphine | Film, Extended Release;Transdermal | Purdue Pharma Lp | Labeling Revision |
| Celexa | citalopram hydrobromide | Tablet;Oral | Forest Labs | Labeling Revision |
| Children's Allegra Allergy | fexofenadine hydrochloride | Tablet;Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Children's Allegra Hives | fexofenadine hydrochloride | Tablet;Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Dolophine Hydrochloride | methadone hydrochloride | Syrup;Oral | Roxane | Labeling Revision |
| Dolophine Hydrochloride | methadone hydrochloride | Tablet;Oral | Roxane | Labeling Revision |
| Duragesic-100 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Labeling Revision |
| Duragesic-12 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Labeling Revision |
| Duragesic-25 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Labeling Revision |
| Duragesic-50 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Labeling Revision |
| Duragesic-75 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Labeling Revision |
| Embeda | morphine sulfate; naltrexone hydrochloride | Capsule, Extended Release;Oral | Alpharma King | Labeling Revision |
| Exalgo | hydromorphone hydrochloride | Tablet, Extended Release;Oral | Mallinckrodt Inc | Labeling Revision |
| Kadian | morphine sulfate | Capsule, Extended Release;Oral | Watson Labs Inc | Labeling Revision |
| Lo Minastrin Fe | ethinyl estradiol; norethindrone acetate | Tablet, Chewable, Tablet;Oral | Warner Chilcott | Manufacturing Change or Addition |
| Ms Contin | morphine sulfate | Tablet, Extended Release;Oral | Purdue Pharma Lp | Labeling Revision |
| Nucynta Er | tapentadol hydrochloride | Tablet, Extended Release;Oral | Janssen Pharms | Labeling Revision |
| Opana Er | oxymorphone hydrochloride | Tablet, Extended Release;Oral | Endo Pharms | Labeling Revision |
| Opana Er | oxymorphone hydrochloride | Tablet, Extended Release;Oral | Endo Pharms | Labeling Revision |
| Oxycontin | oxycodone hydrochloride | Tablet, Extended Release;Oral | Purdue Pharma Lp | Labeling Revision |
| Palladone | hydromorphone hydrochloride | Capsule, Extended Release;Oral | Purdue Pharma Lp | Labeling Revision |
| Pradaxa | dabigatran etexilate mesylate | Capsule;Oral | Boehringer Ingelheim | Manufacturing Change or Addition |
| Xulane | norelgestromin; ethinyl estradiol | System; Transdermal | Mylan Technologies | Approval |
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