Application 021476
- Type
- NDA
- Sponsor
- SUNOVION PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LUNESTA | ESZOPICLONE | TABLET;ORAL | 1MG | Yes | No |
| 002 | LUNESTA | ESZOPICLONE | TABLET;ORAL | 2MG | Yes | No |
| 003 | LUNESTA | ESZOPICLONE | TABLET;ORAL | 3MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 21695-225 | Lunesta | eszopiclone | Rebel Distributors Corp | NDA | Current |
| 21695-226 | Lunesta | eszopiclone | Rebel Distributors Corp | NDA | Current |
| 50436-0193 | Lunesta | ESZOPICLONE | Unit Dose Services | NDA | Current |
| 52959-852 | Lunesta | ESZOPICLONE | H.J. Harkins Company, Inc. | NDA | Current |
| 52959-919 | Lunesta | ESZOPICLONE | H.J. Harkins Company, Inc. | NDA | Current |
| 55289-014 | Lunesta | ESZOPICLONE | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-014 | Lunesta | ESZOPICLONE | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-014 | Lunesta | ESZOPICLONE | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-014 | Lunesta | ESZOPICLONE | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 55289-014 | Lunesta | ESZOPICLONE | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
| 63402-190 | Lunesta | ESZOPICLONE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-190 | Lunesta | ESZOPICLONE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-190 | Lunesta | ESZOPICLONE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-190 | Lunesta | ESZOPICLONE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-191 | Lunesta | ESZOPICLONE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-191 | Lunesta | ESZOPICLONE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-191 | Lunesta | ESZOPICLONE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-191 | Lunesta | ESZOPICLONE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-193 | Lunesta | ESZOPICLONE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-193 | Lunesta | ESZOPICLONE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-193 | Lunesta | ESZOPICLONE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63402-193 | Lunesta | ESZOPICLONE | Sunovion Pharmaceuticals Inc. | NDA | Current |
| 63629-3142 | Lunesta | ESZOPICLONE | Bryant Ranch Prepack | NDA | Current |
| 68258-7048 | Lunesta | ESZOPICLONE | Dispensing Solutions, Inc. | NDA | Current |
| 68258-7049 | Lunesta | ESZOPICLONE | Dispensing Solutions, Inc. | NDA | Current |