Orange Book product
AMOXICILLIN AND CLAVULANATE POTASSIUM 500MG;EQ 125MG BASE
Orange Book ANDA 209992 · REGCON HOLDINGS LLC · Prescription
Key facts
| Proprietary name | AMOXICILLIN AND CLAVULANATE POTASSIUM |
|---|---|
| Active ingredients | AMOXICILLIN, CLAVULANATE POTASSIUM |
| Strength | 500MG;EQ 125MG BASE |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA209992 |
| Applicant holder | REGCON HOLDINGS LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Sep 15, 2023 |
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.