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INAPSINE

NDA

DROPERIDOL | N016796 | RISING PHARMA HOLDINGS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Anthea Pharma Private Limited FDA-2025-P-5430 Anthea Pharma Private Limited filed this citizen petition requesting that the FDA Commissioner determine whether INAPSINE (droperidol) Injection, 2.5 mg/mL, approved under NDA N016796 and held by Rising Pharma Holdings Inc, was withdrawn from sale for safety or effectiveness reasons. The petitioner	Other	2025-10-16	Denied	Anthea Pharma Private Limited

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs3 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

JOINT STOCK CO GRINDEKSDROPERIDOL USP

DMF 229752009

MEHTA API PVT LTDDROPERIDOL USP

DMF 421102025

NV ORGANONInactiveDROPERIDOL

DMF 57731985

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPAInactiveDROPERIDOL

DMF 75391988

XIAN LIBANG PHARMACEUTICAL CO LTDInactiveDROPERIDOL USP, NON-STERILE BULK DRUG INTENDED FOR HUMAN USE

DMF 138971998

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 16, 2003	SUPPL -39	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.