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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211393
Company: HIKMA
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
02/28/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211393Orig1s000ltr.pdf

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
MIGRANAL DIHYDROERGOTAMINE MESYLATE 0.5MG/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 020148 BAUSCH
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