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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.

SODIUM BICARBONATE

NDANot in Orange Book

SODIUM BICARBONATE | N220790 | AMNEAL EU LTD

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 Chain6 active DMFs3 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

ACS DOBFAR SPASODIUM BICARBONATE, STERILE

DMF 125851997

VM CHEMICALSSODIUM BICARBONATE BP

DMF 290382015

EMNAR PHARMA PRIVATE LTDSODIUM BICARBONATE USP

DMF 324362018

GLOBAL CALCIUM PRIVATE LTDSODIUM BICARBONATE USP

DMF 386702023

ALIVUS LIFE SCIENCES LTDSODIUM BICARBONATE USP

DMF 397802024

MAITHRI DRUGS PRIVATE LTDSODIUM BICARBONATE USP

DMF 434372025

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveSODIUM BICARBONATE USP (STERILE)

DMF 200902006

PFIZER HEALTHCARE INDIA PVT LTDInactiveSODIUM BICARBONATE (STERILE)

DMF 216892008

AURONEXT PHARMA PRIVATE LTDInactiveSODIUM BICARBONATE (STERILE)

DMF 293002015

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 10, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 150MEQ/1,000ML (0.15MEQ/ML)

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INJECTABLE;INTRAVENOUS | Approved: Jul. 9, 2026

No patent or exclusivity listings for this strength.