What's New on the FDA Drugs Site
October 2, 2015
- CDER Statement: FDA alerts health care professionals and patients not to use sterile drug products from Chen Shwezin Inc., dba Park Compounding Pharmacy
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA approves Keytruda (pembrolizumab) for advanced non-small cell lung cancer.
- National Drug Code Directory
New and Generic Drug Approvals
October 1, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Adderall 10 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | Tablet;Oral | Teva Womens | Labeling Revision |
| Adderall 12.5 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | Tablet;Oral | Teva Womens | Labeling Revision |
| Adderall 15 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | Tablet;Oral | Teva Womens | Labeling Revision |
| Adderall 20 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | Tablet;Oral | Teva Womens | Labeling Revision |
| Adderall 30 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | Tablet;Oral | Teva Womens | Labeling Revision |
| Adderall 5 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | Tablet;Oral | Teva Womens | Labeling Revision |
| Adderall 7.5 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | Tablet;Oral | Teva Womens | Labeling Revision |
| Eloxatin | oxaliplatin | Injectable;Iv (Infusion) | Sanofi Aventis Us | Labeling Revision |
| Xtandi | enzalutamide | Capsule;Oral | Astellas | Labeling Revision |
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Monday, October 5, 2015
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