Application 091024
- Type
- ANDA
- Sponsor
- DR REDDYS LABS 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 |
|---|
| 50090-5084 | Eszopiclone | Eszopiclone | A-S Medication Solutions | ANDA | Current |
| 50436-0619 | Eszopiclone | Eszopiclone | Unit Dose Services | ANDA | Current |
| 53217-307 | Eszopiclone | Eszopiclone | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55111-617 | Eszopiclone | Eszopiclone | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-617 | Eszopiclone | Eszopiclone | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-619 | Eszopiclone | Eszopiclone | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-619 | Eszopiclone | Eszopiclone | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-629 | Eszopiclone | Eszopiclone | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-629 | Eszopiclone | Eszopiclone | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55700-583 | Eszopiclone | Eszopiclone | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 70518-0815 | Eszopiclone | Eszopiclone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0815 | Eszopiclone | Eszopiclone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0815 | Eszopiclone | Eszopiclone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0815 | Eszopiclone | Eszopiclone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0816 | Eszopiclone | Eszopiclone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0816 | Eszopiclone | Eszopiclone | REMEDYREPACK INC. | ANDA | Current |
| 80425-0064 | Lunesta | Eszopiclone 2mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0064 | Eszopiclone | Eszopiclone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0064 | Eszopiclone | Eszopiclone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0064 | Eszopiclone | Eszopiclone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0067 | Lunesta | Eszopiclone 3mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0067 | Eszopiclone | Eszopiclone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0067 | Eszopiclone | Eszopiclone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0067 | Eszopiclone | Eszopiclone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31512 | ORIG | 2014-04-16 |