Application 209347
- Type
- NDA
- Sponsor
- EXELA PHARMA SCS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GANZYK-RTU | GANCICLOVIR | SOLUTION;INTRAVENOUS | 500MG/250ML (2MG/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51754-2500 | GANCICLOVIR | GANCICLOVIR | EXELA PHARMA SCIENCES, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 52673 | ORIG | 2018-02-20 |
| 49865 | SUPPL | 2017-09-27 |
| 49835 | SUPPL | 2017-09-22 |
| 47266 | ORIG | 2017-02-21 |
| 47265 | ORIG | 2017-02-21 |