Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050805
Company: GALDERMA LABS LP
Company: GALDERMA LABS LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORACEA | DOXYCYCLINE | 40MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/02/2025 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050805s020lbl.pdf | |
| 12/15/2021 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050805s011lbl.pdf | |
| 07/25/2013 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050805s008lbl.pdf | |
| 11/07/2012 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050805s007lbl.pdf | |
| 05/13/2010 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050805s002lbl.pdf | |
| 05/26/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050805lbl.pdf |