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NORFLEX

NDA

ORPHENADRINE CITRATE | N013055 | PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES 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 Odin Pharmaceuticals, LLC FDA-2022-P-0585 Odin Pharmaceuticals, LLC filed this citizen petition under 21 C.F.R. §§ 10.25, 10.30 and sections 505(j) and 505(w) of the FDC Act requesting that the FDA determine whether NORFLEX (Orphenadrine Citrate) Injection, 30 mg/mL, approved under NDA 013055, was withdrawn for reasons of safety or effectiv	505(q)	2022-04-13	Denied	Odin Pharmaceuticals

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs3 inactive

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

W R GRACE AND CO -CONNORPHENADRINE CITRATE USP

DMF 57221985

PROCOS SPAORPHENADRINE CITRATE

DMF 149712000

R L FINE CHEM PVT LTDORPHENADRINE CITRATE

DMF 339012019

R L FINE CHEM PVT LTDORPHENADRINE CITRATE

DMF 384562023

ORGAMOL SAInactiveORPHENADRINE CITRATE AND ORPHENADRINE HCL.

DMF 48111983

3M PHARMACEUTICALSInactiveORPHENADRINE CITRATE

DMF 71081987

IROPHARM LTDInactiveORPHENADRINE CITRATE

DMF 78371988

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 14, 2008	SUPPL -21	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.