An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 215228
Company: SOMERSET THERAPS LLC

Products on ANDA 215228

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215228

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215228

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 RESEARCH
DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	215228	SOMERSET THERAPS LLC
MIGRANAL	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	Yes	AB	020148	BAUSCH

Top