Application 021720
- Type
- NDA
- Sponsor
- EISAI INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARICEPT ODT | DONEPEZIL HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | Yes | No |
| 002 | ARICEPT ODT | DONEPEZIL HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62856-831 | Aricept | donepezil hydrochloride | Eisai Inc. | NDA | Current |
| 62856-831 | Aricept | donepezil hydrochloride | Eisai Inc. | NDA | Current |
| 62856-831 | Aricept | donepezil hydrochloride | Eisai Inc. | NDA | Current |
| 62856-831 | Aricept | donepezil hydrochloride | Eisai Inc. | NDA | Current |
| 62856-832 | Aricept | donepezil hydrochloride | Eisai Inc. | NDA | Current |
| 62856-832 | Aricept | donepezil hydrochloride | Eisai Inc. | NDA | Current |
| 62856-832 | Aricept | donepezil hydrochloride | Eisai Inc. | NDA | Current |
| 62856-832 | Aricept | donepezil hydrochloride | Eisai Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56931 | SUPPL | 2018-12-21 |
| 56791 | SUPPL | 2018-12-19 |
| 28456 | SUPPL | 2015-07-22 |
| 16255 | SUPPL | 2015-07-22 |
| 6045 | SUPPL | 2013-09-10 |
| 37516 | SUPPL | 2013-09-09 |
| 28454 | SUPPL | 2013-04-09 |
| 16254 | SUPPL | 2012-09-26 |
| 6044 | SUPPL | 2012-09-06 |
| 16253 | SUPPL | 2012-03-09 |
| 28455 | SUPPL | 2012-03-05 |
| 37515 | SUPPL | 2010-12-01 |
| 6043 | SUPPL | 2010-11-30 |
| 37514 | SUPPL | 2006-10-18 |
| 28453 | SUPPL | 2006-10-18 |
| 21788 | ORIG | 2006-06-08 |
| 16252 | ORIG | 2004-10-22 |
| 6042 | ORIG | 2004-10-22 |