Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213650
Company: PERRIGO UK FINCO
Company: PERRIGO UK FINCO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SUMATRIPTAN | SUMATRIPTAN | 5MG/SPRAY | SPRAY;NASAL | 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 |
---|---|---|---|---|---|---|---|
09/21/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
SUMATRIPTAN
SPRAY;NASAL; 5MG/SPRAY
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IMITREX | SUMATRIPTAN | 5MG/SPRAY | SPRAY;NASAL | Prescription | Yes | AB | 020626 | GLAXOSMITHKLINE |
SUMATRIPTAN | SUMATRIPTAN | 5MG/SPRAY | SPRAY;NASAL | Prescription | No | AB | 204841 | LANNETT CO INC |
SUMATRIPTAN | SUMATRIPTAN | 5MG/SPRAY | SPRAY;NASAL | Prescription | No | AB | 213465 | PADAGIS ISRAEL |
SUMATRIPTAN | SUMATRIPTAN | 5MG/SPRAY | SPRAY;NASAL | Prescription | No | AB | 213650 | PERRIGO UK FINCO |