Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022239
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SUMAVEL DOSEPRO | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Discontinued | None | Yes | No |
SUMAVEL DOSEPRO | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/15/2009 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022239lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022239s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022239_sumavel_dosepro_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022239s000Sumr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/02/2020 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022239s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022239Orig1s007ltr.pdf | |
12/26/2019 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022239s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022239Orig1s006ltr.pdf | |
11/26/2013 | SUPPL-5 | Efficacy-Manufacturing Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022239s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022239Orig1s005ltr.pdf | |
06/02/2016 | SUPPL-4 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022239s004lbl.pdf | |
06/27/2011 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022239s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022239s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/02/2020 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022239s007lbl.pdf | |
12/26/2019 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022239s006lbl.pdf | |
06/02/2016 | SUPPL-4 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022239s004lbl.pdf |
11/26/2013 | SUPPL-5 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022239s005lbl.pdf | |
06/27/2011 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022239s002lbl.pdf | |
07/15/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022239lbl.pdf |