Viewing data from:

VELOSEF '250'

NDA

CEPHRADINE | N050548 | ERSANA INC SUB ER SQUIBB AND SONS

2 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 Chain0 active DMFs10 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SMITHKLINE BEECHAM PHARMACEUTICALSInactiveCEPHRADINE

DMF 135011998

BRISTOL MYERS SQUIBB INDUSTRIAL DIVInactiveCEPHRADINE

DMF 135021998

BRISTOL MYERS SQUIBB COInactiveCEPHRADINE

DMF 135411998

BRISTOL MYERS SQUIBB COInactiveCEPHRADINE

DMF 135421998

LARKInactiveCEPHRADINE

DMF 135951998

ACS DOBFAR SPAInactiveCEPHRADINE MONOHYDRATE

DMF 136131998

ERSANA INCInactiveCEPHRADINE DIHYDRATE

DMF 136261998

TEVA PHARMACEUTICALS USA INCInactiveCEPHRADINE

DMF 137931998

CHEMFERM SAInactiveCEPHRADINE

DMF 137461998

JK DRUGS AND PHARMACEUTICALS LTDInactiveCEPHRADINE USP

DMF 145281999

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

Products (2)

Sort:

#001 — 250MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 500MG

0 patents0 exclusivities▾

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