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PATHOCIL

NDA

DICLOXACILLIN SODIUM | N050011 | WYETH AYERST LABORATORIES

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 Chain1 active DMF8 inactive

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

APITORIA PHARMA PRIVATE LTDDICLOXACILLIN SODIUM USP

DMF 195532006

CONSOLIDATED PHARMACEUTICAL GROUP INCInactiveDICLOXACILLIN SODIUM

DMF 132211998

FERMENTA PRODUCTS INCInactiveDICLOXACILLIN SODIUM

DMF 133521998

BRISTOL MYERS SQUIBB COInactiveDICLOXACILLIN SODIUM

DMF 134291998

BRISTOL MYERS SQUIBB COInactiveDICLOXACILLIN SODIUM

DMF 134311998

SMITHKLINE BEECHAM PHARMACEUTICALSInactiveDICLOXACILLIN SODIUM MONOHYDRATE

DMF 134971998

BARCELONETA INC DIV BRISTOL MYERSInactiveDICLOXACILLIN SODIUM

DMF 135581998

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveDICLOXACILLIN SODIUM

DMF 136571998

SANDOZ INDUSTRIAL PRODUCTS SAInactiveDICLOXACILLIN SODIUM

DMF 137981998

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

Products (2)

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#002 — EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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#003 — EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: Mar 28, 1983