All regulations
Nonrulemaking
FDA
FDA-2012-P-1180
Determine That an Abbreviated New Drug Application (ANDA) Oxycodone Hydrochloride Extended-Release Capsules may be Submitted and be Considered Bioequivalent to the Reference Listed Drug (RLD) Oxycontin® (Oxycodone Hydrochloride Controlled-Release) Tablets
Documents
5
Comments
1
Description
CLOSED
Key Dates
Comment Period OpensDec 20, 2012
Documents
| Type | Title | Status |
|---|---|---|
Other |
Comment Statistics
Total Comments
1
Keywords
cder
2012-9568
ANDA
oxycodone hydrochloride controlled-release
Oxycontin
tablets
bioequivalent
oral
oxycodone
Data from Regulations.gov