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Details for New Drug Application (NDA): 091577

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NDA 091577 describes METHYLERGONOVINE MALEATE, which is a drug marketed by Novel Labs Inc, Ergoject, and Luitpold, and is included in three NDAs. It is available from eight suppliers. Additional details are available on the METHYLERGONOVINE MALEATE profile page.

The generic ingredient in METHYLERGONOVINE MALEATE is methylergonovine maleate. There is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the methylergonovine maleate profile page.

Summary for NDA: 091577

Novel Labs Inc
methylergonovine maleate

Pharmacology for NDA: 091577


Suppliers and Packaging for NDA: 091577

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
methylergonovine maleate
TABLET;ORAL 091577 ANDA KAISER FOUNDATION HOSPITALS 0179-0122 0179-0122-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0122-70)
methylergonovine maleate
TABLET;ORAL 091577 ANDA Lupin Pharma 27437-050 27437-050-01 100 TABLET in 1 BOTTLE (27437-050-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.2MG
Approval Date:May 2, 2011TE:RLD:Yes

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