Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078067
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Discontinued | None | No | No |
SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 4MG BASE/0.5ML (EQ 8MG 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 |
---|---|---|---|---|---|---|---|
02/06/2009 | ORIG-1 | Approval |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078067Orig1s000LBL.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/21/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
07/21/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/06/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078067Orig1s000LBL.pdf |