Application 208451
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ESZOPICLONE | ESZOPICLONE | TABLET;ORAL | 1MG | No | No |
| 002 | ESZOPICLONE | ESZOPICLONE | TABLET;ORAL | 2MG | No | No |
| 003 | ESZOPICLONE | ESZOPICLONE | TABLET;ORAL | 3MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-3514 | ESZOPICLONE | ESZOPICLONE | A-S Medication Solutions | ANDA | Current |
| 50090-3514 | ESZOPICLONE | ESZOPICLONE | A-S Medication Solutions | ANDA | Current |
| 50090-3514 | ESZOPICLONE | ESZOPICLONE | A-S Medication Solutions | ANDA | Current |
| 50090-3553 | ESZOPICLONE | ESZOPICLONE | A-S Medication Solutions | ANDA | Current |
| 50090-3553 | ESZOPICLONE | ESZOPICLONE | A-S Medication Solutions | ANDA | Current |
| 50090-4202 | ESZOPICLONE | ESZOPICLONE | A-S Medication Solutions | ANDA | Current |
| 50090-4202 | ESZOPICLONE | ESZOPICLONE | A-S Medication Solutions | ANDA | Current |
| 65862-967 | ESZOPICLONE | ESZOPICLONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-967 | ESZOPICLONE | ESZOPICLONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-967 | ESZOPICLONE | ESZOPICLONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-967 | ESZOPICLONE | ESZOPICLONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-967 | ESZOPICLONE | ESZOPICLONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-968 | ESZOPICLONE | ESZOPICLONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-968 | ESZOPICLONE | ESZOPICLONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-968 | ESZOPICLONE | ESZOPICLONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-968 | ESZOPICLONE | ESZOPICLONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-968 | ESZOPICLONE | ESZOPICLONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-969 | ESZOPICLONE | ESZOPICLONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-969 | ESZOPICLONE | ESZOPICLONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-969 | ESZOPICLONE | ESZOPICLONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-969 | ESZOPICLONE | ESZOPICLONE | Aurobindo Pharma Limited | ANDA | Current |
| 65862-969 | ESZOPICLONE | ESZOPICLONE | Aurobindo Pharma Limited | ANDA | Current |
| 68788-7667 | ESZOPICLONE | ESZOPICLONE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7667 | ESZOPICLONE | ESZOPICLONE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7667 | ESZOPICLONE | ESZOPICLONE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-1310 | ESZOPICLONE | ESZOPICLONE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1310 | ESZOPICLONE | ESZOPICLONE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1310 | ESZOPICLONE | ESZOPICLONE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1310 | ESZOPICLONE | ESZOPICLONE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1310 | ESZOPICLONE | ESZOPICLONE | REMEDYREPACK INC. | ANDA | Current |
| 70518-3395 | ESZOPICLONE | ESZOPICLONE | REMEDYREPACK INC. | ANDA | Current |
| 70518-3395 | ESZOPICLONE | ESZOPICLONE | REMEDYREPACK INC. | ANDA | Current |
| 71205-236 | ESZOPICLONE | ESZOPICLONE | Proficient Rx LP | ANDA | Current |
| 71205-236 | ESZOPICLONE | ESZOPICLONE | Proficient Rx LP | ANDA | Current |
| 71205-236 | ESZOPICLONE | ESZOPICLONE | Proficient Rx LP | ANDA | Current |
| 71205-236 | ESZOPICLONE | ESZOPICLONE | Proficient Rx LP | ANDA | Current |
| 71205-384 | ESZOPICLONE | ESZOPICLONE | Proficient Rx LP | ANDA | Current |
| 71205-384 | ESZOPICLONE | ESZOPICLONE | Proficient Rx LP | ANDA | Current |
| 71205-513 | ESZOPICLONE | ESZOPICLONE | Proficient Rx LP | ANDA | Current |
| 71335-1662 | ESZOPICLONE | ESZOPICLONE | Bryant Ranch Prepack | ANDA | Current |
| 71335-1662 | ESZOPICLONE | ESZOPICLONE | Bryant Ranch Prepack | ANDA | Current |
| 72789-067 | ESZOPICLONE | ESZOPICLONE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-067 | ESZOPICLONE | ESZOPICLONE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-067 | ESZOPICLONE | ESZOPICLONE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-067 | ESZOPICLONE | ESZOPICLONE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-067 | ESZOPICLONE | ESZOPICLONE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 80425-0063 | Lunesta | Eszopiclone 2mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0063 | Lunesta | Eszopiclone 2mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0063 | Eszopiclone | Eszopiclone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0063 | Eszopiclone | Eszopiclone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0066 | Lunesta | Eszopiclone 3mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0066 | Eszopiclone | Eszopiclone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0066 | Eszopiclone | Eszopiclone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |