Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202278
Company: TEVA BRANDED PHARM
Company: TEVA BRANDED PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZECUITY | SUMATRIPTAN SUCCINATE | EQ 6.5MG BASE/4HR | SYSTEM;IONTOPHORESIS | 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 |
|---|---|---|---|---|---|---|---|
| 01/17/2013 | 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/2013/202278s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202278Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202278Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202278Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/07/2015 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/2014 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/2015 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/2014 | SUPPL-2 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202278s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202278Orig1s001,s002ltr.pdf | |
| 03/21/2014 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202278s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202278Orig1s001,s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/21/2014 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202278s001s002lbl.pdf | |
| 03/21/2014 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202278s001s002lbl.pdf | |
| 01/17/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202278s000lbl.pdf |