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Last Updated: September 26, 2022

Details for New Drug Application (NDA): 020148


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NDA 020148 describes MIGRANAL, which is a drug marketed by Bausch and is included in one NDA. It is available from two suppliers. Additional details are available on the MIGRANAL profile page.

The generic ingredient in MIGRANAL is dihydroergotamine mesylate. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the dihydroergotamine mesylate profile page.
Summary for 020148
Tradename:MIGRANAL
Applicant:Bausch
Ingredient:dihydroergotamine mesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020148
Medical Subject Heading (MeSH) Categories for 020148
Suppliers and Packaging for NDA: 020148
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIGRANAL dihydroergotamine mesylate SPRAY, METERED;NASAL 020148 NDA Bausch Health US, LLC 0187-0245 0187-0245-01 1 VIAL in 1 KIT (0187-0245-01) > 1 mL in 1 VIAL
MIGRANAL dihydroergotamine mesylate SPRAY, METERED;NASAL 020148 NDA Bausch Health US, LLC 0187-0245 0187-0245-03 8 VIAL in 1 KIT (0187-0245-03) > 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.5MG/SPRAY
Approval Date:Dec 8, 1997TE:ABRLD:Yes

Expired US Patents for NDA 020148

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch MIGRANAL dihydroergotamine mesylate SPRAY, METERED;NASAL 020148-001 Dec 8, 1997 See Plans and Pricing See Plans and Pricing
Bausch MIGRANAL dihydroergotamine mesylate SPRAY, METERED;NASAL 020148-001 Dec 8, 1997 See Plans and Pricing See Plans and Pricing
Bausch MIGRANAL dihydroergotamine mesylate SPRAY, METERED;NASAL 020148-001 Dec 8, 1997 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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