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Application 205494
- Type
- NDA
- Sponsor
- GENZYME CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CERDELGA | ELIGLUSTAT TARTRATE | CAPSULE;ORAL | EQ 84MG BASE | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 58468-0220 | Cerdelga | eliglustat | Genzyme Corporation | NDA | Current |
| 58468-0220 | Cerdelga | eliglustat | Genzyme Corporation | NDA | Current |
| 58468-0220 | Cerdelga | eliglustat | Genzyme Corporation | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 56239 | SUPPL | 2018-11-01 |
| 55469 | SUPPL | 2018-09-13 |
| 55376 | SUPPL | 2018-08-31 |
| 52743 | ORIG | 2018-02-28 |
| 24496 | ORIG | 2014-09-17 |
| 22993 | ORIG | 2014-09-17 |
| 19653 | ORIG | 2014-08-22 |
| 10455 | ORIG | 2014-08-20 |