Details for New Drug Application (NDA): 040889
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NDA 040889 describes METHYLERGONOVINE MALEATE, which is a drug marketed by Am Regent, Breckenridge, Amneal Pharms, Chartwell Rx, Granules, Rising, Teva Pharms Usa, and Tulex Pharms Inc, and is included in eight NDAs. It is available from twelve 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. Twelve suppliers are listed for this compound. 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. Twelve suppliers are listed for this compound. Additional details are available on the methylergonovine maleate profile page.
Summary for 040889
| Tradename: | METHYLERGONOVINE MALEATE |
| Applicant: | Breckenridge |
| Ingredient: | methylergonovine maleate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 040889
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHYLERGONOVINE MALEATE | methylergonovine maleate | INJECTABLE;INJECTION | 040889 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1556 | 51662-1556-1 | 1 mL in 1 AMPULE (51662-1556-1) |
| METHYLERGONOVINE MALEATE | methylergonovine maleate | INJECTABLE;INJECTION | 040889 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-144 | 51991-144-17 | 10 AMPULE in 1 BOX (51991-144-17) / 1 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.2MG/ML | ||||
| Approval Date: | Sep 13, 2010 | TE: | AP | RLD: | No | ||||
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