Viewing data from:

Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

TINDAMAX

NDANot in Orange Book

TINIDAZOLE | N021682 | MISSION PHARMA

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 DMF5 inactive

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

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDTINIDAZOLE (NON-STERILE DRUG SUBSTANCE)

DMF 188242005

PFIZER INCInactiveTINIDAZOLE BULK

DMF 17041971

PFIZER LABORATORIES DIV PFIZER INCInactiveTINIDAZOLE

DMF 62261985

FARCHEMIA SRLInactiveTINIDAZOLE USP XXI

DMF 62751986

PFIZER SAInactiveTINIDAZOLE

DMF 65441986

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactiveTINIDAZOLE

DMF 103501993

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

Products (2)

Sort:

#001 — 250MG

▴

TABLET; ORAL | Approved: May. 17, 2004

No patent or exclusivity listings for this strength.

#002 — 500MG

▾

TABLET; ORAL | Approved: May. 17, 2004