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LODINE XL

NDA

ETODOLAC | N020584 | WYETH PHARMACEUTICALS INC

3 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

2 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 4 -Etodolac PI Revision -re: Suitability Petition from Pharmobedie... FDA-2023-P-4877 Pharmobedient Consulting filed a petition regarding the suitability of etodolac, seeking revisions to the product information for this nonsteroidal anti-inflammatory drug. The specific regulatory mechanism and detailed requested action are not explicitly stated in the provided text excerpt.	Suitability	2023-11-03	Open	Pharmobedient Consulting
Attachment 5 -ETODOLAC TABLETS USP- re: Suitability Petition from Pharmobedie... FDA-2023-P-4877 Pharmobedient Consulting filed a petition regarding etodolac tablets USP, requesting that the FDA determine the suitability of this drug substance and formulation for use in abbreviated new drug applications (ANDAs) to facilitate generic drug development and approval.	Suitability	2023-11-03	Open	Pharmobedient Consulting

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain11 active DMFs11 inactive

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

AMSA SPAETODOLAC

DMF 113591995

ZAKLADY FARMACEUTYCZNE POLPHARMA SAETODOLAC

DMF 114051995

TAPI NL BVETODOLAC

DMF 117661995

TARO PHARMACEUTICAL INDUSTRIES LTDETODOLAC USP MICRONIZED

DMF 153392001

ZHEJIANG CHIRAL MEDICINE CHEMICALS CO LTDETODOLAC

DMF 167892003

ZYDUS LIFESCIENCES LTDETODOLAC USP

DMF 236882010

KREATIVE ORGANICS PRIVATE LTDETODOLAC USP

DMF 244222010

IPCA LABORATORIES LTDETODOLAC USP (ED6 PROCESS)

DMF 248682011

ULKAR KIMYA SANAYII VE TICARET ASETODOLAC

DMF 249362011

EMCURE PHARMACEUTICALS LTDETODOLAC USP

DMF 258082012

IPCA LABORATORIES LTDETODOLAC USP (ED7 PROCESS)

DMF 275122013

LEDERLE LABORATORIES DIV AMERICAN CYANAMID COInactiveETODOLAC (ETODOLIC ACID)

DMF 53461984

UPJOHN COInactiveETODOLAC MICRONIZED AS PROCESSED IN THE KALAMAZOO, MICHIGAN FACILITY

DMF 53831984

LONZA INCInactiveETODOLAC INTERMEDIATES

DMF 54371984

LONZA AGInactiveETODOLAC

DMF 57951985

QUIMICA SINTETICA SAInactiveETODOLAC

DMF 95291992

CHEMI SPAInactiveETODOLAC

DMF 117401995

RANBAXY PHARMACEUTICALS INCInactiveETODOLAC DRUG SUBSTANCE

DMF 126181997

CHEMSOURCE CORPInactiveETODOLAC DRUG SUBSTANCE

DMF 142981999

IPCA LABORATORIES LTDInactiveETODOLAC

DMF 214492008

YANGZHOU PHARMACEUTICAL CO LTDInactiveETODOLAC USP

DMF 215782008

FLEMING LABORATORIES LTDInactiveETODOLAC USP

DMF 319672017

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jan 20, 2006	SUPPL -9	View Letter (PDF)
May 26, 2005	SUPPL -4	View Letter (PDF)
May 26, 2005	SUPPL -6	View Letter (PDF)
May 26, 2005	SUPPL -7	View Letter (PDF)
Aug 11, 2000	SUPPL -5	View Letter (PDF)
May 27, 1999	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 25, 1996

No patent or exclusivity listings for this strength.

#002 — 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Oct 25, 1996

#003 — 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jan 20, 1998