Application 206713
- Type
- ANDA
- Sponsor
- MICRO LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRANEXAMIC ACID | TRANEXAMIC ACID | INJECTABLE;INJECTION | 100MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42571-189 | Tranexamic Acid | Tranexamic Acid | Micro Labs Limited | ANDA | Current |
| 42571-189 | Tranexamic Acid | Tranexamic Acid | Micro Labs Limited | ANDA | Current |
| 42571-189 | Tranexamic Acid | Tranexamic Acid | Micro Labs Limited | ANDA | Current |
| 42571-189 | Tranexamic Acid | Tranexamic Acid | Micro Labs Limited | ANDA | Current |
| 42571-189 | Tranexamic Acid | Tranexamic Acid | Micro Labs Limited | ANDA | Current |
| 42571-314 | TRANEXAMIC ACID | TRANEXAMIC ACID | Micro Labs Limited | ANDA | Current |
| 42571-314 | TRANEXAMIC ACID | TRANEXAMIC ACID | Micro Labs Limited | ANDA | Current |
| 42571-314 | TRANEXAMIC ACID | TRANEXAMIC ACID | Micro Labs Limited | ANDA | Current |
| 42571-314 | TRANEXAMIC ACID | TRANEXAMIC ACID | Micro Labs Limited | ANDA | Current |
| 42571-314 | TRANEXAMIC ACID | TRANEXAMIC ACID | Micro Labs Limited | ANDA | Current |
| 72485-107 | TRANEXAMIC ACID | TRANEXAMIC ACID | Armas Pharmaceuticals Inc. | ANDA | Current |
| 72485-107 | TRANEXAMIC ACID | TRANEXAMIC ACID | Armas Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 48901 | ORIG | 2017-07-05 |