2006P-0520 Determination for Methotrexate Injection, USP, Preservative Free, Eq. 500 mg base/20 mL, NDA 11-719)
FDA Comment Number : EC1
Submitter : Mr. Dave Lowe Date & Time: 01/05/2007 08:01:21
Organization : Mr. Dave Lowe
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I oppose the petition. Attached are Orange Book Active Ingredient Search results (RX) for review.
2006P-0520-EC1-Attach-1.PDF