Approvals (Drugs@FDA)

DIHYDROERGOTAMINE MESYLATE

SOMERSET THERAPS LLC · DIHYDROERGOTAMINE MESYLATE

ANDA215228Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA215228
Sponsor name
SOMERSET THERAPS LLC
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250226
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    DIHYDROERGOTAMINE MESYLATE
    Reference standard
    No
    Dosage form
    SPRAY, METERED
    Route
    NASAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DIHYDROERGOTAMINE MESYLATE
      Strength
      0.5MG/SPRAY
Harmonized identifiers (openFDA)
Application number
ANDA215228
Brand name
DIHYDROERGOTAMINE MESYLATE
Generic name
DIHYDROERGOTAMINE MESYLATE
Manufacturer name
Somerset Therapeutics, LLC
Product NDC
70069-880
Product type
HUMAN PRESCRIPTION DRUG
Route
NASAL
Substance name
DIHYDROERGOTAMINE MESYLATE
RxCUI
861668
SPL ID
8d88a6e3-0b91-4414-acce-4de8bb371ac1
SPL set ID
c8ffdc19-a90d-453c-b094-2347e116b405
Package NDC
70069-880-01, 70069-880-08
UNII
81AXN7R2QT
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.