Details for New Drug Application (NDA): 212233
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NDA 212233 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 thirteen 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. Thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the methylergonovine maleate profile page.
Summary for 212233
| Tradename: | METHYLERGONOVINE MALEATE |
| Applicant: | Tulex Pharms Inc |
| Ingredient: | methylergonovine maleate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212233
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHYLERGONOVINE MALEATE | methylergonovine maleate | TABLET;ORAL | 212233 | ANDA | Volley Pharmaceuticals, LLC | 83400-100 | 83400-100-12 | 12 TABLET in 1 BOTTLE (83400-100-12) |
| METHYLERGONOVINE MALEATE | methylergonovine maleate | TABLET;ORAL | 212233 | ANDA | Volley Pharmaceuticals, LLC | 83400-100 | 83400-100-28 | 28 TABLET in 1 BOTTLE (83400-100-28) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.2MG | ||||
| Approval Date: | May 1, 2020 | TE: | AB | RLD: | No | ||||
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