Requests that the FDA determine whether the Reference Listed Drug (RLD), INAPSINE® (droperidol) Injection, 2.5 mg/mL approved under New Drug Application (NDA) Number N016796, held by Rising Pharma Holdings Inc has not been withdrawn from sale for safety or effectiveness reasons. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-5430

Requests that the FDA determine whether the Reference Listed Drug (RLD), INAPSINE® (droperidol) Injection, 2.5 mg/mL approved under New Drug Application (NDA) Number N016796, held by Rising Pharma Holdings Inc has not been withdrawn from sale for safety or effectiveness reasons.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 16, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to Anthea Pharma Private Ltd.	Apr 1, 2026	--

Keywords

CDER

Citizen Petition

Anthea Pharma Private Limited

determine whether the Reference Listed Drug

INAPSINE droperidol Injection

2 5 mg mL

approved under

New Drug Application Number N016796

Data from Regulations.gov