What's New on the FDA Drugs Site
June 19, 2012
- Drug Firm Annual Registration Status Download File
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortages: Amino Acid Products (updated)
- Drug Shortages: Current Drug Shortages: Fospropofol disodium (Lusedra) injection
- Drug Shortages: Current Drug Shortages: Secretin Injection (ChiRhoStim)
June 18, 2012
- Drug Firm Annual Registration Status Download File
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortages: Corticorelin Ovine Triflutate (updated)
- Drug Shortages: Current Drug Shortages: Demopressin Injection (updated)
- Drug Shortages: Current Drug Shortages: Demospressin Intranasal (updated)
- Drug Shortages: Current Drug Shortages: Etoposide solution for injection (updated)
- Drug Shortages: Current Drug Shortages: Mitomycin Powder for Injection (updated)
- Drug Shortages: Current Drug Shortages: Paclitaxel Injection (updated)
- National Drug Code Directory (updated)
- Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena)
New and Generic Drug Approvals
June 18, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abacavir Sulfate | abacavir sulfate | Tablet; Oral | Mylan Pharms Inc | Approval |
| Modicon 28 | ethinyl estradiol; norethindrone | Tablet; Oral-28 | Janssen Pharms | Labeling Revision |
| Ortho Cyclen-21 | ethinyl estradiol; norgestimate | Tablet; Oral-21 | Janssen Pharms | Labeling Revision |
| Ortho Cyclen-28 | ethinyl estradiol; norgestimate | Tablet; Oral-28 | Janssen Pharms | Labeling Revision |
| Ortho Tri-Cyclen | ethinyl estradiol; norgestimate | Tablet; Oral-21 | Janssen Pharms | Labeling Revision |
| Ortho Tri-Cyclen | ethinyl estradiol; norgestimate | Tablet; Oral-28 | Janssen Pharms | Labeling Revision |
| Ortho Tri-Cyclen Lo | ethinyl estradiol; norgestimate | Tablet; Oral-28 | Janssen Pharms | Labeling Revision |
| Ortho-Cept | desogestrel; ethinyl estradiol | Tablet; Oral-21 | Janssen Pharms | Labeling Revision |
| Ortho-Cept | desogestrel; ethinyl estradiol | Tablet; Oral-28 | Janssen Pharms | Labeling Revision |
| Ortho-Novum 1/35-28 | ethinyl estradiol; norethindrone | Tablet; Oral-28 | Janssen Pharms | Labeling Revision |
| Ortho-Novum 7/7/7-21 | ethinyl estradiol; norethindrone | Tablet; Oral-21 | Janssen Pharms | Labeling Revision |
| Ortho-Novum 7/7/7-28 | ethinyl estradiol; norethindrone | Tablet; Oral-28 | Janssen Pharms | Labeling Revision |
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