Untitled Letters 2018
These letters are supplied by the CDER Freedom of Information Office and only covers Office of Prescription Drug Promotion's untitled letters. The agency may have redacted or edited some of the letters to remove confidential information.
Office of Prescription Drug Promotion
|
Company/Individual |
Product/Issue |
Issue Date |
|---|---|---|
|
Eisai Inc.
|
NDA 202834; 208277 Fycompa (perampanel) oral suspension, CIII Fycompa(perampanel) tablets, for oral use, CIII |
10/11/2018 |
|
ASCEND Therapeutics US, LLC
|
NDA 021166 EstroGel 0.06% (estradiol gel) for topical use |
8/16/2018 |
|
Arog Pharmaceuticals, Inc.
|
Crenolanib besylate |
6/28/2018 |
|
Pfizer Inc.
|
NDA 020472 ESTRING® (estradiol vaginal ring) |
6/19/2018 |
|
Collegium Pharmaceuticals, Inc.
|
NDA 208090 Xtampza ER (oxycodone) extended-release capsules, for oral use |
2/9/2018 |