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Last Updated: September 26, 2022

Details for New Drug Application (NDA): 206621

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NDA 206621 describes DIHYDROERGOTAMINE MESYLATE, which is a drug marketed by Hikma, Hikma Pharms, Padagis Us, Provepharm Sas, Sagent Pharms Inc, Amneal, Cipla, and Custopharm Inc, and is included in eight NDAs. It is available from eight suppliers. Additional details are available on the DIHYDROERGOTAMINE MESYLATE profile page.

The generic ingredient in DIHYDROERGOTAMINE MESYLATE 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 206621
Applicant:Hikma Pharms
Ingredient:dihydroergotamine mesylate
Formulation / Manufacturing:see details
Pharmacology for NDA: 206621
Medical Subject Heading (MeSH) Categories for 206621
Suppliers and Packaging for NDA: 206621
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIHYDROERGOTAMINE MESYLATE dihydroergotamine mesylate INJECTABLE;INJECTION 206621 ANDA Hikma Pharmaceuticals USA Inc. 0143-9273 0143-9273-10 10 AMPULE in 1 CARTON (0143-9273-10) > 1 mL in 1 AMPULE (0143-9273-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Sep 15, 2017TE:APRLD:No

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