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METHYLERGONOVINE MALEATE

ANDA

METHYLERGONOVINE MALEATE | A090193 | AMERICAN REGENT INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TAPI NL BVMETHYLERGONOVINE MALEATE USP

DMF 189882005

ZHEJIANG BOXIAO BIOPHARMACEUTICAL CO LTDMETHYLERGONOVINE MALEATE (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 403432024

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 28, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.2MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Nov 24, 2008

No patent or exclusivity listings for this strength.