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QUELICIN PRESERVATIVE FREE

NDA

SUCCINYLCHOLINE CHLORIDE | N008845 | HOSPIRA INC

4 strengths0 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

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

5 letters from Drugs@FDA

Date	Submission	Document
Nov 2, 2022	SUPPL -80	View Letter (PDF)
Feb 22, 2022	SUPPL -79	View Letter (PDF)
Aug 12, 2021	SUPPL -76	View Letter (PDF)
Jul 30, 2018	SUPPL -73	View Letter (PDF)
Nov 30, 2010	SUPPL -65	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#006 — 20MG/ML

RLDAP

0 patents0 exclusivities▾

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

#001 — 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.

#002 — 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

#004 — 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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