Application 207961
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 31722-621 | Dabigatran Etexilate | Dabigatran Etexilate | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-621 | Dabigatran Etexilate | Dabigatran Etexilate | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-622 | Dabigatran Etexilate | Dabigatran Etexilate | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-622 | Dabigatran Etexilate | Dabigatran Etexilate | Camber Pharmaceuticals, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 63416 | ORIG | 2020-06-04 |