All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2026-P-5122
Requests that the FDA declare that an ANDA may be submitted for, Prazosin Hydrochloride Capsules, USP 3 mg and 4 mg, two strength’s that differ from the currently approved RLD, MINIPRESS (Prazosin Hydrochloride) capsules from PFIZER LABORATORIES DIV PFIZER INC., which FDA approved in 1 mg, 2 mg, and 5 mg strengths prior to Jan 1, 1982 under NDA #017442.
Documents
6
Comments
0
Key Dates
Comment Period OpensMay 8, 2026
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CDER
Suitability Petition
Appco Pharma LLC
declare that an ANDA may be submitted for
Prazosin Hydrochloride Capsules
USP 3 mg and 4 mg
two strengths
that differ from the currently approved
Data from Regulations.gov