1
/
of
0
Summary Basis of Approval Request – ANDAs 218366 (Carnegie Pharmaceuticals) & 214896 (Rubicon Research Private Ltd.)
Summary Basis of Approval Request – ANDAs 218366 (Carnegie Pharmaceuticals) & 214896 (Rubicon Research Private Ltd.)
Regular price
$69.00 USD
Regular price
Sale price
$69.00 USD
Unit price
/
per
Request Contents: Summary basis of approval requested for ANDAs:
218366 (approved on January 23, 2024) - Carnegie Pharmaceuticals.
214896 (approved on June 28, 2022 - 50 mg, 250 mg; December 28, 2022 - 125 mg) - Rubicon Research Private Ltd.
Couldn't load pickup availability
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
View full details