Application 212654
- Type
- ANDA
- Sponsor
- UPSHER SMITH LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 002 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 003 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
| 004 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 75MG | No | No |
| 005 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
| 006 | AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 150MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0832-1220 | Amitriptyline hydrochloride | Amitriptyline hydrochloride | Upsher-smith Laboratories, LLC | ANDA | Current |
| 0832-1221 | Amitriptyline hydrochloride | Amitriptyline hydrochloride | Upsher-Smith Laboratories, LLC | ANDA | Current |
| 0832-1222 | Amitriptyline hydrochloride | Amitriptyline hydrochloride | Upsher-smith Laboratories, LLC | ANDA | Current |
| 0832-1223 | Amitriptyline hydrochloride | Amitriptyline hydrochloride | Upsher-smith Laboratories, LLC | ANDA | Current |
| 0832-1224 | Amitriptyline hydrochloride | Amitriptyline hydrochloride | Upsher-smith Laboratories, LLC | ANDA | Current |
| 0832-1225 | Amitriptyline hydrochloride | Amitriptyline hydrochloride | Upsher-smith Laboratories, LLC | ANDA | Current |