Orange Book product
OXYBUTYNIN CHLORIDE 5MG
Orange Book ANDA 210717 · BIONPHARMA INC · Prescription
Key facts
| Proprietary name | OXYBUTYNIN CHLORIDE |
|---|---|
| Active ingredients | OXYBUTYNIN CHLORIDE |
| Strength | 5MG |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Application | ANDA210717 |
| Applicant holder | BIONPHARMA INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Dec 17, 2019 |
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.