All regulations
Nonrulemaking
FDA
FDA-2000-P-0764
ANDA for Elixir Containing 10mg Hydrocodone Bitartrate/650mg
Documents
1
Comments
0
Description
CLOSED DATE: 08/30/2000 Docket Status: CLOSED Remarks: (SEE 00P-1243/CP2)
Key Dates
Comment Period OpensJul 31, 2024
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
10MG HYDROCOCONE
BITARTRATE/650MG
ELIXIR
ACETAMINOPHEN PER 30ML.
ACUTE ABDOMINAL CONDITION
MODERATE/SEVERE PAIN
PHARMACEUTICAL ASSOCIATES
CDER
Data from Regulations.gov