Application 214200
- Type
- NDA
- Sponsor
- G1 THERAPEUTICS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | COSELA | TRILACICLIB | INJECTABLE;INJECTION | 300MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73462-101 | Cosela | trilaciclib | G1 Therapeutics, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83213 | SUPPL | 2025-08-27 |
| 83198 | SUPPL | 2025-08-26 |
| 74999 | SUPPL | 2023-08-04 |
| 74981 | SUPPL | 2023-08-04 |
| 73967 | SUPPL | 2023-04-10 |
| 73954 | SUPPL | 2023-04-06 |
| 66773 | ORIG | 2021-03-12 |
| 66579 | ORIG | 2021-03-08 |
| 66228 | ORIG | 2021-02-16 |