Details for New Drug Application (NDA): 210424
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NDA 210424 describes METHYLERGONOVINE MALEATE, which is a drug marketed by Am Regent, Breckenridge, Amneal Pharms, Chartwell Rx, Granules, Rising, Teva Pharms Usa, and Trupharma, 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 210424
| Tradename: | METHYLERGONOVINE MALEATE |
| Applicant: | Granules |
| Ingredient: | methylergonovine maleate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210424
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHYLERGONOVINE MALEATE | methylergonovine maleate | TABLET;ORAL | 210424 | ANDA | West-Ward Pharmaceuticals Corp | 0054-0639 | 0054-0639-05 | 12 TABLET in 1 BOTTLE (0054-0639-05) |
| METHYLERGONOVINE MALEATE | methylergonovine maleate | TABLET;ORAL | 210424 | ANDA | Major Pharmaceuticals | 0904-7282 | 0904-7282-10 | 20 BLISTER PACK in 1 CARTON (0904-7282-10) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.2MG | ||||
| Approval Date: | May 15, 2018 | TE: | AB | RLD: | No | ||||
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