Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212907
Company: CIPLA
Company: CIPLA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIHYDROERGOTAMINE MESYLATE | DIHYDROERGOTAMINE MESYLATE | 0.5MG/SPRAY | SPRAY, METERED;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 |
---|---|---|---|---|---|---|---|
05/20/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212907Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/12/2023 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
DIHYDROERGOTAMINE MESYLATE
SPRAY, METERED;NASAL; 0.5MG/SPRAY
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIHYDROERGOTAMINE MESYLATE | DIHYDROERGOTAMINE MESYLATE | 0.5MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 212907 | CIPLA |
DIHYDROERGOTAMINE MESYLATE | DIHYDROERGOTAMINE MESYLATE | 0.5MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 211393 | HIKMA |
DIHYDROERGOTAMINE MESYLATE | DIHYDROERGOTAMINE MESYLATE | 0.5MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 216881 | RUBICON |
MIGRANAL | DIHYDROERGOTAMINE MESYLATE | 0.5MG/SPRAY | SPRAY, METERED;NASAL | Prescription | Yes | AB | 020148 | BAUSCH |