Application 208040
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | CAPSULE;ORAL | EQ 75MG BASE | No | No |
| 002 | DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | CAPSULE;ORAL | EQ 150MG BASE | No | No |
| 003 | DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | CAPSULE;ORAL | EQ 110MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67877-474 | Dabigatran Etexilate | Dabigatran Etexilate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-474 | Dabigatran Etexilate | Dabigatran Etexilate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-474 | Dabigatran Etexilate | Dabigatran Etexilate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-475 | Dabigatran Etexilate | Dabigatran Etexilate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-475 | Dabigatran Etexilate | Dabigatran Etexilate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-475 | Dabigatran Etexilate | Dabigatran Etexilate | Ascend Laboratories, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 62987 | ORIG | 2020-05-14 |