Untitled Letters 2019
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 |
|---|---|---|
|
Rockwell Medical, Inc
|
NDA 206317; NDA 208551 TRIFERIC (ferric pyrophosphate citrate) solution and TRIFERIC® (ferric pyrophosphate citrate) powder packet for addition to bicarbonate concentration | 11/18/2019 |
|
Nascent Biotech, Inc.
|
Pritumumab | 11/1/2019 |
|
Kowa Pharmaceuticals, Inc.
|
NDA 022363 Livalo (pitavastatin) tablet, for oral use | 9/24/2019 |
|
CooperSurgical, Inc.
|
NDA 018680 ParaGard T380A INTRAUTERINE COPPER CONTRACEPTIVE | 7/25/2019 |
|
Aclaris Therapeutics, Inc.
|
NDA 209305 ESKATA (hydrogen peroxide) topical solution | 6/14/2019 |
|
VIVUS, Inc.
|
NDA 022580 QSYMIA (phentermine and topiramate extended-release) capsules, for oral use, CIV |
5/22/2019 |
|
Phoenix Molecular Imaging Center
|
Sodium Acetate (C-11) | 2/15/2019 |