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Application 208723
- Type
- NDA
- Sponsor
- ACTAVIS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVOLEUCOVORIN CALCIUM | LEVOLEUCOVORIN CALCIUM | POWDER;INTRAVENOUS | EQ 175MG BASE/VIAL | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-4130 | Levoleucovorin | Levoleucovorin | Actavis Pharma, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 47700 | SUPPL | 2017-03-24 |
| 47664 | SUPPL | 2017-03-24 |
| 45817 | ORIG | 2016-11-04 |
| 45580 | ORIG | 2016-10-06 |
| 45579 | ORIG | 2016-10-03 |