Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018741
Company: ORGANON
Company: ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIPROLENE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED;TOPICAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/01/2019 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018741s040lbl.pdf | |
| 03/28/2018 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018741s038lbl.pdf | |
| 08/13/2014 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018741s036lbl.pdf | |
| 08/28/2006 | SUPPL-28 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s028lbl.pdf | |
| 10/07/2005 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018741s016lbl.pdf | |
| 10/07/2005 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018741s016lbl.pdf |