Application 204806
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | CAPSULE;ORAL | EQ 100MG BASE | No | No |
| 002 | ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | CAPSULE;ORAL | EQ 150MG BASE | No | No |
| 003 | ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | CAPSULE;ORAL | EQ 200MG BASE | No | No |
| 004 | ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | CAPSULE;ORAL | EQ 300MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-6875 | Atazanavir Sulfate | Atazanavir | Major Pharmaceuticals | ANDA | Current |
| 0904-6875 | Atazanavir Sulfate | Atazanavir | Major Pharmaceuticals | ANDA | Current |
| 16714-860 | Atazanavir Sulfate | Atazanavir | NorthStar Rx LLC | ANDA | Current |
| 16714-860 | Atazanavir Sulfate | Atazanavir | NorthStar Rx LLC | ANDA | Current |
| 16714-860 | Atazanavir Sulfate | Atazanavir | NorthStar Rx LLC | ANDA | Current |
| 16714-861 | Atazanavir Sulfate | Atazanavir | NorthStar Rx LLC | ANDA | Current |
| 16714-861 | Atazanavir Sulfate | Atazanavir | NorthStar Rx LLC | ANDA | Current |
| 16714-861 | Atazanavir Sulfate | Atazanavir | NorthStar Rx LLC | ANDA | Current |
| 16714-862 | Atazanavir Sulfate | Atazanavir | NorthStar Rx LLC | ANDA | Current |
| 16714-862 | Atazanavir Sulfate | Atazanavir | NorthStar Rx LLC | ANDA | Current |
| 16714-862 | Atazanavir Sulfate | Atazanavir | NorthStar Rx LLC | ANDA | Current |
| 60687-399 | Atazanavir Sulfate | Atazanavir | American Health Packaging | ANDA | Current |
| 60687-399 | Atazanavir Sulfate | Atazanavir | American Health Packaging | ANDA | Current |
| 65862-710 | Atazanavir Sulfate | Atazanavir | Aurobindo Pharma Limited | ANDA | Current |
| 65862-710 | Atazanavir Sulfate | Atazanavir | Aurobindo Pharma Limited | ANDA | Current |
| 65862-710 | Atazanavir Sulfate | Atazanavir | Aurobindo Pharma Limited | ANDA | Current |
| 65862-711 | Atazanavir Sulfate | Atazanavir | Aurobindo Pharma Limited | ANDA | Current |
| 65862-711 | Atazanavir Sulfate | Atazanavir | Aurobindo Pharma Limited | ANDA | Current |
| 65862-711 | Atazanavir Sulfate | Atazanavir | Aurobindo Pharma Limited | ANDA | Current |
| 65862-712 | Atazanavir Sulfate | Atazanavir | Aurobindo Pharma Limited | ANDA | Current |
| 65862-712 | Atazanavir Sulfate | Atazanavir | Aurobindo Pharma Limited | ANDA | Current |
| 65862-712 | Atazanavir Sulfate | Atazanavir | Aurobindo Pharma Limited | ANDA | Current |
| 65862-713 | Atazanavir Sulfate | Atazanavir | Aurobindo Pharma Limited | ANDA | Current |
| 65862-713 | Atazanavir Sulfate | Atazanavir | Aurobindo Pharma Limited | ANDA | Current |
| 65862-713 | Atazanavir Sulfate | Atazanavir | Aurobindo Pharma Limited | ANDA | Current |
| 70518-1365 | Atazanavir Sulfate | Atazanavir | REMEDYREPACK INC. | ANDA | Current |
| 70518-1365 | Atazanavir Sulfate | Atazanavir | REMEDYREPACK INC. | ANDA | Current |
| 70518-1365 | Atazanavir Sulfate | Atazanavir | REMEDYREPACK INC. | ANDA | Current |
| 70518-1365 | Atazanavir Sulfate | Atazanavir | REMEDYREPACK INC. | ANDA | Current |
| 70518-1365 | Atazanavir Sulfate | Atazanavir | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10397 | ORIG | 2014-02-04 |