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NDA

NAFCILLIN SODIUM | N050320 | WYETH AYERST LABORATORIES

6 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 Chain3 active DMFs4 inactive

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

ACS DOBFAR SPANAFCILLIN SODIUM FOR INJECTION (BULK)

DMF 136951998

APITORIA PHARMA PRIVATE LTDNAFCILLIN SODIUM (NON-STERILE DRUG SUBSTANCE INTERMEDIATE)

DMF 224732009

ACS DOBFAR SPANAFCILLIN SODIUM FOR INJECTION (STERILE BULK)

DMF 273132013

FERMENTA PRODUCTS INCInactiveNAFCILLIN SODIUM

DMF 133871998

SMITHKLINE BEECHAM PHARMACEUTICALSInactiveNAFCILLIN SODIUM

DMF 135541998

LATINA PHARMA SPAInactiveNAFCILLIN SODIUM STERILE

DMF 136531998

ACS DOBFAR SPAInactiveNAFCILLIN SODIUM

DMF 136971998

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

Products (6)

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#001 — EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴