Orange Book product
BONTRIL PDM 35MG
Orange Book ANDA 085272 · BAUSCH HEALTH US LLC · Prescription
Key facts
| Proprietary name | BONTRIL PDM |
|---|---|
| Active ingredients | PHENDIMETRAZINE TARTRATE |
| Strength | 35MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA085272 |
| Applicant holder | BAUSCH HEALTH US LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Jan 1, 1982 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes 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.