Application 206511
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TELMISARTAN | TELMISARTAN | TABLET;ORAL | 20MG | No | No |
| 002 | TELMISARTAN | TELMISARTAN | TABLET;ORAL | 40MG | No | No |
| 003 | TELMISARTAN | TELMISARTAN | TABLET;ORAL | 80MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65862-867 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-867 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-867 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-867 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-867 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-867 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-867 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-867 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-868 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-868 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-868 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-868 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-868 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-868 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-868 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-868 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-869 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-869 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-869 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-869 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-869 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-869 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-869 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-869 | Telmisartan | Telmisartan | Aurobindo Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 32813 | ORIG | 2015-09-08 |