Application 091198
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | No | No |
| 002 | DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-5276 | Donepezil Hydrochloride | donepezil hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5276 | Donepezil Hydrochloride | donepezil hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5277 | Donepezil Hydrochloride | donepezil hydrochloride | Sandoz Inc | ANDA | Current |
| 0781-5277 | Donepezil Hydrochloride | donepezil hydrochloride | Sandoz Inc | ANDA | Current |