Details for New Drug Application (NDA): 090193
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The generic ingredient in METHYLERGONOVINE MALEATE is methylergonovine maleate. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the methylergonovine maleate profile page.
Summary for 090193
Tradename: | METHYLERGONOVINE MALEATE |
Applicant: | Am Regent |
Ingredient: | methylergonovine maleate |
Patents: | 0 |
Suppliers and Packaging for NDA: 090193
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METHYLERGONOVINE MALEATE | methylergonovine maleate | INJECTABLE;INJECTION | 090193 | ANDA | American Regent, Inc. | 0517-0740 | 0517-0740-20 | 20 VIAL, SINGLE-DOSE in 1 CARTON (0517-0740-20) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-0740-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.2MG/ML | ||||
Approval Date: | Nov 24, 2008 | TE: | AP | RLD: | No |
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