Application 078662
- Type
- ANDA
- Sponsor
- ACI HEALTHCARE LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 71093-127 | Donepezil Hydrochloride | Donepezil Hydrochloride | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-127 | Donepezil Hydrochloride | Donepezil Hydrochloride | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-127 | Donepezil Hydrochloride | Donepezil Hydrochloride | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-127 | Donepezil Hydrochloride | Donepezil Hydrochloride | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-127 | Donepezil Hydrochloride | Donepezil Hydrochloride | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-128 | Donepezil Hydrochloride | Donepezil Hydrochloride | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-128 | Donepezil Hydrochloride | Donepezil Hydrochloride | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-128 | Donepezil Hydrochloride | Donepezil Hydrochloride | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-128 | Donepezil Hydrochloride | Donepezil Hydrochloride | ACI Healthcare USA, Inc. | ANDA | Current |
| 71093-128 | Donepezil Hydrochloride | Donepezil Hydrochloride | ACI Healthcare USA, Inc. | ANDA | Current |
| 71335-2065 | Donepezil Hydrochloride | Donepezil Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-2065 | Donepezil Hydrochloride | Donepezil Hydrochloride | Bryant Ranch Prepack | ANDA | Current |