Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090358
Company: SUN PHARM
Company: SUN PHARM
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 | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
06/21/2011 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/090358Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/06/2023 | SUPPL-29 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
10/29/2019 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
05/22/2019 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
02/09/2016 | SUPPL-11 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
02/09/2016 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
02/09/2016 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
03/14/2014 | SUPPL-1 | Labeling |
Label is not available on this site. |
SUMATRIPTAN SUCCINATE
INJECTABLE;SUBCUTANEOUS; EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IMITREX STATDOSE | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AB | 020080 | GLAXOSMITHKLINE |
SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AB | 090495 | DR REDDYS |
SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AB | 090358 | SUN PHARM |