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CEFOTAN

NDA

CEFOTETAN DISODIUM | N050588 | PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC

3 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 DMF1 inactive

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

ACS DOBFAR SPACEFOTETAN DISODIUM (STERILE BULK)

DMF 189772005

ASTELLAS PHARMA INCInactiveCEFOTETAN

DMF 50741983

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

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 27, 1985

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#002 — EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 27, 1985

#003 — EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 25, 1988