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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/26/2006 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050805lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050805s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050805s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/15/2021 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050805s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050805Orig1s011ltr.pdf | |
09/03/2015 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/24/2015 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/25/2013 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050805s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050805Orig1s008ltr.pdf | |
11/07/2012 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050805s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050805Orig1s007ltr.pdf | |
05/13/2010 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050805s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050805s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
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 |
ORACEA
CAPSULE;ORAL; 40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXYCYCLINE | DOXYCYCLINE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 217674 | ALEMBIC |
DOXYCYCLINE | DOXYCYCLINE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 217170 | APOTEX |
DOXYCYCLINE | DOXYCYCLINE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 218034 | DR REDDYS |
DOXYCYCLINE | DOXYCYCLINE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 216631 | LUPIN |
ORACEA | DOXYCYCLINE | 40MG | CAPSULE;ORAL | Prescription | Yes | AB | 050805 | GALDERMA LABS LP |