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SUCCINYLCHOLINE CHLORIDE

NDA

SUCCINYLCHOLINE CHLORIDE | N215143 | HIKMA PHARMACEUTICALS USA INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

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Today

12295932

Nov. 2, 2041

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs2 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

SOLARA ACTIVE PHARMA SCIENCES LTDSUCCINYLCHOLINE CHLORIDE

DMF 228922009

DELMAR CHEMICALS INCSUCCINYLCHOLINE CHLORIDE

DMF 232242009

HARMAN FINOCHEM LTDSUCCINYLCHOLINE CHLORIDE USP

DMF 319862017

MANKIND PHARMA LTDSUCCINYLCHOLINE CHLORIDE USP

DMF 372452022

XIAN LIBANG PHARMACEUTICAL CO LTDInactiveSUCCINYLCHOLINE CHLORIDE

DMF 228072009

MAC CHEM PRODUCTS INDIA PVT LTDInactiveSUCCINYLCHOLINE CHLORIDE USP

DMF 254402011

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Nov 2, 2022	SUPPL -2	View Letter (PDF)
Mar 18, 2022	SUPPL -1	View Letter (PDF)
Aug 24, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/5ML (20MG/ML)

RLD

1 patent0 exclusivities▴

SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Approved: Aug 20, 2021

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
12295932	Nov 2, 2041	—	—	Yes	—	—