1
/
of
0
FDA NDA 050715 – Cyclosporine Capsule Dissolution Testing Info
FDA NDA 050715 – Cyclosporine Capsule Dissolution Testing Info
Regular price
$69.00 USD
Regular price
Sale price
$69.00 USD
Unit price
/
per
Original Request: Pursuant to § 505(j) of FD&C Act & 21 CFR § 314.94 Ascent Pharmaceuticals, Inc., (“Ascent”), is planning to submit an Abbreviated New Drug Application (ANDA) in eCTD format for Cyclosporine Capsule, USP 25 mg, 50 mg and 100 mg and basis of submission (RLD) details are listed below. We are hereby requesting the agency to provide “Freedom of Information” of NDA# 050715 in specific to drug product dissolution testing media and volume
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