All regulations
Nonrulemaking
FDA
FDA-2008-P-0218
Determine Whether a 1 gm/20 mL (50 mg/mL) Presentation of Fluorouracil Injection, USP Can Be Added to Ebewe Pharma's Existing ANDA 40-772 Fluorouracil Injection USP 50 mg/mL (500 mg/10mL)
Documents
4
Comments
0
Description
Docket Status: CLOSED CLOSED: 12/2/2008 - Petition Withdrawal received(ue)
Key Dates
Comment Period OpensDec 2, 2008
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
500 mg/10mL
ANDA 40-772
Ebewe Pharma
Fluorouracil Injection
USP
50 MG/ML
1 gm/20 mL
CDER
Data from Regulations.gov