Orange Book product
ACTOPLUS MET 850MG;EQ 15MG BASE
Orange Book NDA 021842 · TAKEDA PHARMACEUTICALS USA INC · Prescription
Key facts
| Proprietary name | ACTOPLUS MET |
|---|---|
| Active ingredients | METFORMIN HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE |
| Strength | 850MG;EQ 15MG BASE |
| Dosage form | TABLET |
| Route | ORAL |
| Application | NDA021842 |
| Applicant holder | TAKEDA PHARMACEUTICALS USA INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Aug 29, 2005 |
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.