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GLYCOPHOS

NDA

SODIUM GLYCEROPHOSPHATE | N220381 | FRESENIUS KABI USA LLC

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 Chain2 active DMFs

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

GLOBAL CALCIUM PRIVATE LTDSODIUM GLYCEROPHOSPHATE HYDRATED

DMF 391312023

MACCO ORGANIQUES SROSODIUM GLYCEROPHOSPHATE, HYDRATED

DMF 402152024

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 30, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 4.32GM/20ML (216MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jul 29, 2026

No patent or exclusivity listings for this strength.

#002 — 21.6GM/100ML (216MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jul 29, 2026