Orange Book product
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE 62.5MG;25MG
Orange Book ANDA 202362 · MYLAN PHARMACEUTICALS INC · Prescription
Key facts
| Proprietary name | ATOVAQUONE AND PROGUANIL HYDROCHLORIDE |
|---|---|
| Active ingredients | ATOVAQUONE, PROGUANIL HYDROCHLORIDE |
| Strength | 62.5MG;25MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA202362 |
| Applicant holder | MYLAN PHARMACEUTICALS INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | May 27, 2014 |
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.