Orange Book product
AMITRIPTYLINE HYDROCHLORIDE 75MG
Orange Book ANDA 218389 · UNIQUE PHARMACEUTICAL LABORATORIES · Prescription
Key facts
| Proprietary name | AMITRIPTYLINE HYDROCHLORIDE |
|---|---|
| Active ingredients | AMITRIPTYLINE HYDROCHLORIDE |
| Strength | 75MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA218389 |
| Applicant holder | UNIQUE PHARMACEUTICAL LABORATORIES |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jun 23, 2025 |
At a glance
- 10–99 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.