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DIHYDROERGOTAMINE MESYLATE

ANDA

DIHYDROERGOTAMINE MESYLATE | A211393 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: MIGRANAL(TE code: AB)

API Supply Chain4 active DMFs2 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVDIHYDROERGOTAMINE MESYLATE

DMF 149442000

CURIA ITALY SRLDIHYDROERGOTAMINE MESYLATE USP/EP

DMF 224072009

OLON SPADIHYDROERGOTAMINE MESYLATE

DMF 304972016

OLON SPADIHYDROERGOTAMINE MESYLATE

DMF 330222018

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveDIHYDROERGOTAMINE MESYLATE

DMF 102421993

LEK PHARMACEUTICALS DDInactiveDIHYDROERGOTAMINE MESYLATE

DMF 161942002

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 17, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5MG/SPRAY

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Feb 28, 2020

No patent or exclusivity listings for this strength.