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NDA

CEFMETAZOLE SODIUM | N050637 | PHARMACIA AND UPJOHN CO

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 DMF2 inactive

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

SUZHOU HOMESUN PHARMACEUTICAL CO LTDCEFMETAZOLE SODIUM

DMF 273812013

SANKYO CO LTDInactiveCEFMETAZOLE SODIUM INJECTION(VIALS)

DMF 59521985

SANKYO CO LTDInactiveCEFMETAZOLE (FREE ACID)

DMF 98871982

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

Products (2)

Sort:

#001 — EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 11, 1989

No patent or exclusivity listings for this strength.

#002 — EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 11, 1989