Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022159
Company: SEPTODONT HOLDING
Company: SEPTODONT HOLDING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ORAVERSE | PHENTOLAMINE MESYLATE | 0.4MG/1.7ML | INJECTABLE;INJECTION | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
05/09/2008 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
Review Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022159s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022159_oraverse_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/022159s000_SUMR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/07/2016 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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03/18/2016 | SUPPL-11 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022159s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022159Orig1s011ltr.pdf | |
01/26/2015 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/26/2015 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/05/2015 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/09/2014 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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09/09/2013 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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01/09/2014 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/18/2016 | SUPPL-11 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022159s011lbl.pdf |