Application 201146
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS 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 |
|---|
| 0615-7951 | Donepezil Hydrochloride | Donepezil Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7951 | Donepezil Hydrochloride | Donepezil Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7952 | Donepezil Hydrochloride | Donepezil Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7952 | Donepezil Hydrochloride | Donepezil Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8313 | Donepezil Hydrochloride | Donepezil Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 33342-027 | Donepezil Hydrochloride | Donepezil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-027 | Donepezil Hydrochloride | Donepezil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-027 | Donepezil Hydrochloride | Donepezil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-028 | Donepezil Hydrochloride | Donepezil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-028 | Donepezil Hydrochloride | Donepezil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-028 | Donepezil Hydrochloride | Donepezil Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 43063-659 | Donepezil Hydrochloride | Donepezil Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-659 | Donepezil Hydrochloride | Donepezil Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-659 | Donepezil Hydrochloride | Donepezil Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-659 | Donepezil Hydrochloride | Donepezil Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-659 | Donepezil Hydrochloride | Donepezil Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-659 | Donepezil Hydrochloride | Donepezil Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 60687-171 | Donepezil Hydrochloride | Donepezil Hydrochloride | American Health Packaging | ANDA | Current |
| 61919-692 | Donepezil Hydrochloride | Donepezil Hydrochloride | Direct Rx | ANDA | Current |
| 63629-8050 | Donepezil Hydrochloride | Donepezil Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8050 | Donepezil Hydrochloride | Donepezil Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0416 | Donepezil Hydrochloride | Donepezil Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0416 | Donepezil Hydrochloride | Donepezil Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-2022 | Donepezil Hydrochloride | Donepezil Hydrochloride | Bryant Ranch Prepack | ANDA | Current |