FdaApplication
ANDA 218389
Identifiers
- fda_app_no: ANDA218389
Properties
| Property | Value |
|---|---|
| applicant_name | UNIQUE PHARMACEUTICAL LABORATORIES |
| application_type | ANDA |
| approval_date | 2025-06-23 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | TABLET;ORAL |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL |
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL |
6 products