Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040453
Company: HIKMA
Company: HIKMA
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 |
---|---|---|---|---|---|---|---|
06/09/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/040453.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/08/2023 | SUPPL-9 | Labeling-Package Insert, 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 |