Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078318
Company: TEVA PARENTERAL
Company: TEVA PARENTERAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Discontinued | None | No | No |
| SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 07/29/2008 | ORIG-1 | Tentative Approval |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078318Orig1s000LBL.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/29/2008 | ORIG-1 | Tentative Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078318Orig1s000LBL.pdf |