Orange Book product
PACERONE 400MG
Orange Book ANDA 075135 · UPSHER SMITH LABORATORIES LLC · Prescription
Key facts
| Proprietary name | PACERONE |
|---|---|
| Active ingredients | AMIODARONE HYDROCHLORIDE |
| Strength | 400MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA075135 |
| Applicant holder | UPSHER SMITH LABORATORIES LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jul 2, 2020 |
At a glance
- 1–9 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.