Application 212035
- Type
- NDA
- Sponsor
- ACCORD HLTHCARE INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ARGATROBAN | ARGATROBAN | INJECTABLE;INJECTION | 50MG/50ML (1MG/ML) | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16729-430 | ARGATROBAN | Argatroban | Accord Healthcare Inc. | NDA | Current |
| 16729-430 | ARGATROBAN | Argatroban | Accord Healthcare Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 69282 | ORIG | 2021-11-09 |
| 67743 | ORIG | 2021-06-08 |
| 57931 | ORIG | 2019-03-08 |