Application 203713
- Type
- ANDA
- Sponsor
- DEXCEL PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | TABLET;ORAL | 23MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43547-382 | donepezil hydrochloride | donepezil hydrochloride | Solco Healthcare US, LLC | ANDA | Current |
| 43547-382 | donepezil hydrochloride | donepezil hydrochloride | Solco Healthcare US, LLC | ANDA | Current |
| 63629-1117 | donepezil hydrochloride | donepezil hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1117 | donepezil hydrochloride | donepezil hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1118 | donepezil hydrochloride | donepezil hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1118 | donepezil hydrochloride | donepezil hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 64239-404 | Donepezil Hydrochloride | Donepezil Hydrochloride | Dexcel Pharma Technologies Ltd. | ANDA | Current |