Skip to contentApplication 214235
- Type
- ANDA
- Sponsor
- CAPLIN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ARGATROBAN | ARGATROBAN | INJECTABLE;INJECTION | 50MG/50ML (1MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 25021-414 | Argatroban | Argatroban | Sagent Pharmaceuticals | ANDA | Current |
| 25021-414 | Argatroban | Argatroban | Sagent Pharmaceuticals | ANDA | Current |
| 65145-126 | ARGATROBAN | Argatroban | Caplin Steriles Limited | ANDA | Current |
| 65219-429 | Argatroban | Argatroban | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 66060 | ORIG | 2021-02-02 |