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Application 090193
- Type
- ANDA
- Sponsor
- AM REGENT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METHYLERGONOVINE MALEATE | METHYLERGONOVINE MALEATE | INJECTABLE;INJECTION | 0.2MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0517-0740 | Methylergonovine Maleate | Methylergonovine Maleate | American Regent, Inc. | ANDA | Current |
| 0517-0740 | Methylergonovine Maleate | Methylergonovine Maleate | American Regent, Inc. | ANDA | Current |
| 0517-0740 | Methylergonovine Maleate | Methylergonovine Maleate | American Regent, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 39608 | ORIG | 2009-01-16 |
| 9262 | ORIG | 2008-11-28 |