Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Cipla USA Inc.
078719707
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Mipharm SpA
Cipla USA Inc.
Cipla USA Inc.
514042399
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dihydroergotamine Mesylate Nasal
Product Details
NDC Product Code
69097-503Application Number
ANDA212907Marketing Category
ANDA (C73584)Route of Administration
NASALEffective Date
January 24, 2024DihydroergotamineActive
Code: 81AXN7R2QTClass: ACTIBQuantity: 4 mg in 1 mL
CAFFEINEInactive
Code: 3G6A5W338EClass: IACT
ANHYDROUS DEXTROSEInactive
Code: 5SL0G7R0OKClass: IACT
CARBON DIOXIDEInactive
Code: 142M471B3JClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT