Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212046
Company: PROVEPHARM SAS
Company: PROVEPHARM SAS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIHYDROERGOTAMINE MESYLATE | DIHYDROERGOTAMINE MESYLATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
01/07/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/28/2024 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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08/28/2024 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
DIHYDROERGOTAMINE MESYLATE
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIHYDROERGOTAMINE MESYLATE | DIHYDROERGOTAMINE MESYLATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215623 | GLAND PHARMA LTD |
DIHYDROERGOTAMINE MESYLATE | DIHYDROERGOTAMINE MESYLATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040453 | HIKMA |
DIHYDROERGOTAMINE MESYLATE | DIHYDROERGOTAMINE MESYLATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206621 | HIKMA PHARMS |
DIHYDROERGOTAMINE MESYLATE | DIHYDROERGOTAMINE MESYLATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040475 | PADAGIS US |
DIHYDROERGOTAMINE MESYLATE | DIHYDROERGOTAMINE MESYLATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212046 | PROVEPHARM SAS |
DIHYDROERGOTAMINE MESYLATE | DIHYDROERGOTAMINE MESYLATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207264 | SAGENT PHARMS INC |