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NDA

CEPHALEXIN | N050405 | PRAGMA PHARMACEUTICALS LLC

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 Chain8 active DMFs22 inactive

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

CENTRIENT PHARMACEUTICALS NETHERLANDS BVCEPHALEXIN MONOHYDRATE

DMF 132101998

ANTIBIOTICOS SACEPHALEXIN MONOHYDRATE

DMF 135881998

ACS DOBFAR SPACEPHALEXIN MONOHYDRATE

DMF 136121998

ORCHID PHARMA LTDCEPHALEXIN USP

DMF 151062000

LUPIN LTDCEPHALEXIN USP

DMF 172772004

APITORIA PHARMA PRIVATE LTDCEPHALEXIN USP

DMF 176042004

APITORIA PHARMA PRIVATE LTDCEPHALEXIN USP (ENZYMATIC ROUTE)

DMF 329302019

LUPIN LTDCEPHALEXIN USP (ENZYMATIC)

DMF 413572025

GLAXO LABORATORIES SAInactiveCEPHALEXIN

DMF 18201971

ELI LILLY AND COInactiveCEPHALEXIN HYDROCHLORIDE,BULK

DMF 60901985

ELANCO QUIMICA LIMITADAInactiveCEPHALEXIN DISOLVATE

DMF 98891992

LILLY RESEARCH LABORATORIESInactiveCEPHALEXIN MONOHYDRATE

DMF 133851998

LARKInactiveCEPHALEXIN MONOHYDRATE

DMF 135191998

ISFInactiveCEPHALEXIN MONOHYDRATE

DMF 135341998

ANTIBIOTICOSInactiveCEPHALEXIN MONOHYDRATE

DMF 135641998

DISTA PRODUCTS CO DIV ELI LILLY AND COInactiveCEPHALEXIN

DMF 136101998

BRISTOL MYERS SQUIBB COInactiveCEPHALEXIN

DMF 137231998

YOSHITOMI PHARMACEUTICAL INDUSTRIES LTDInactiveCEPHALEXIN

DMF 137151998

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveCEPHALEXIN

DMF 137191998

SQUIBB MFGInactiveCEPHALEXIN

DMF 137201998

BENZEX LABORATORIES LTDInactiveCEPHALEXIN

DMF 137331998

BIOCHEMIE SAInactiveCEPHALEXIN

DMF 137471998

LUPIN LTDInactiveCEPHALEXIN

DMF 137521998

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveCEPHALEXIN USP

DMF 137591998

TAIWAN BIOTECH CO LTDInactiveCEPHALEXIN

DMF 137811998

JK DRUGS AND PHARMACEUTICALS LTDInactiveCEPHALEXIN USP

DMF 142661999

LILLY RESEARCH LABORATORIES DIV ELI LILLY AND COInactiveCEPHALEXIN MONOHYDRATE BULK

DMF 149202000

UNIMARK REMEDIES LTDInactiveCEPHALEXIN USP

DMF 183612005

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveCEPHALEXIN USP (COMPACTED)

DMF 191622006

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTDInactiveCEPHALEXIN USP "YUNG SHIN"

DMF 238722010

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Dec 21, 2018	SUPPL -108	View Letter (PDF)
Dec 21, 2018	SUPPL -107	View Letter (PDF)
Nov 4, 2015	SUPPL -106	View Letter (PDF)
Sep 17, 2008	SUPPL -101	View Letter (PDF)
May 21, 2008	SUPPL -99	View Letter (PDF)
May 16, 2006	SUPPL -97	View Letter (PDF)
Dec 2, 2004	SUPPL -92	View Letter (PDF)
Jul 1, 2004	SUPPL -95	View Letter (PDF)
Jan 22, 2004	SUPPL -94	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#002 — EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

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

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

#004 — EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 12, 2006

#005 — EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 12, 2006