Regulations.gov document
Reference 17 - "FDA/CDER Memorandum, May 30, 2008, Reconsideration of the Approval of ANDA…
Supporting & Related Material · FDA-2009-P-0423 · posted Jan 20, 2010
Key facts
| Document ID | FDA-2009-P-0423-0013 |
|---|---|
| Title | Reference 17 - "FDA/CDER Memorandum, May 30, 2008, Reconsideration of the Approval of ANDA 77-524; Spear Pharmaceuticals Fouorouacil Cream, USP 5% for the Treatment of Acitinic Keratosis (AK) and Superficial Basl Cell Carcinoma" - [Graceway Pharmaceuticals, LLC - Citizen Petition] re FDA-2009-P-0423-0009 |
| Document type | Supporting & Related Material |
| Subtype | CP-Citizen Petition (Supporting & Related Materials) |
| Agency | FDA |
| Docket | FDA-2009-P-0423 |
| Posted | Jan 20, 2010 |
At a glance
- None Public comments on this docket
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