Application 205570
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARGATROBAN IN SODIUM CHLORIDE | ARGATROBAN | INJECTABLE;INTRAVENOUS | 125MG/125ML (1MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68083-141 | Argatroban | Argatroban | Gland Pharma Limited | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 48643 | ORIG | 2017-06-05 |