Orange Book product
SEVELAMER CARBONATE 2.4GM/PACKET
Orange Book ANDA 211316 · IMPAX LABORATORIES LLC · Prescription
Key facts
| Proprietary name | SEVELAMER CARBONATE |
|---|---|
| Active ingredients | SEVELAMER CARBONATE |
| Strength | 2.4GM/PACKET |
| Dosage form | FOR SUSPENSION |
| Route | ORAL |
| Application | ANDA211316 |
| Applicant holder | IMPAX LABORATORIES LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Nov 20, 2020 |
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.