All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2026-P-2443
Requests that the FDA to revise the Draft Guidance on Cariprazine Hydrochloride, RLD or RS number 204370 on Product-Specific Guidances for Generic Drug Development Database to include the information of cariprazine hydrochloride capsules, 0.5 mg and cariprazine hydrochloride Capsules, 0.75 mg
Documents
4
Comments
0
Description
Open
Key Dates
Comment Period OpensMar 10, 2026
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CDER
Citizen Petition
HQ Pharma (Shanghai) Co., Ltd.
Requests that the FDA to revise the
Draft Guidance on Cariprazine Hydrochloride, RLD
or RS number 204370 on Product-Specific
Guidances for Generic Drug Development Database
to include the information of
Data from Regulations.gov