Application 206512
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | TABLET;ORAL | EQ 5MG BASE;160MG | No | No |
| 002 | AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | TABLET;ORAL | EQ 5MG BASE;320MG | No | No |
| 003 | AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | TABLET;ORAL | EQ 10MG BASE;160MG | No | No |
| 004 | AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | TABLET;ORAL | EQ 10MG BASE;320MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 45865-890 | Amlodipine and valsartan | Amlodipine and valsartan | medsource pharmaceuticals | ANDA | Current |
| 65862-737 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-737 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-737 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-737 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-737 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-738 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-738 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-738 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-738 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-738 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-739 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-739 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-739 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-739 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-739 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-740 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-740 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-740 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-740 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |
| 65862-740 | Amlodipine and valsartan | Amlodipine and valsartan | Aurobindo Pharma Limited | ANDA | Current |