Application 205035
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51662-1532 | TRANEXAMIC ACID | TRANEXAMIC ACID | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 55150-188 | Tranexamic Acid | Tranexamic Acid | AuroMedics Pharma LLC | ANDA | Current |
| 55150-188 | Tranexamic Acid | Tranexamic Acid | AuroMedics Pharma LLC | ANDA | Current |
| 55150-188 | Tranexamic Acid | Tranexamic Acid | AuroMedics Pharma LLC | ANDA | Current |
| 55150-188 | Tranexamic Acid | Tranexamic Acid | AuroMedics Pharma LLC | ANDA | Current |
| 55150-188 | Tranexamic Acid | Tranexamic Acid | AuroMedics Pharma LLC | ANDA | Current |
| 55150-188 | Tranexamic Acid | Tranexamic Acid | AuroMedics Pharma LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10418 | ORIG | 2016-01-22 |