Application 210660
- Type
- NDA
- Sponsor
- EXELA PHARMA SCS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ELCYS | CYSTEINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 500MG/10ML (50MG/ML) | Yes | Yes |
| 002 | ELCYS | CYSTEINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 2500MG/50ML (50MG/ML) | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51754-1007 | ELCYS | Cysteine Hydrochloride | Exela Pharma Sciences, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 77118 | SUPPL | 2023-12-22 |
| 77108 | SUPPL | 2023-12-22 |
| 61148 | ORIG | 2019-12-04 |
| 58366 | ORIG | 2019-04-22 |
| 58386 | ORIG | 2019-04-16 |