Orange Book product
QUETIAPINE FUMARATE EQ 300MG BASE
Orange Book ANDA 204253 · MACLEODS PHARMACEUTICALS LTD · Prescription
Key facts
| Proprietary name | QUETIAPINE FUMARATE |
|---|---|
| Active ingredients | QUETIAPINE FUMARATE |
| Strength | EQ 300MG BASE |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Application | ANDA204253 |
| Applicant holder | MACLEODS PHARMACEUTICALS LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Nov 29, 2017 |
At a glance
- 10–99 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.