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SODIUM BICARBONATE IN PLASTIC CONTAINER

NDA

SODIUM BICARBONATE | N019443 | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV

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

4 trials from ClinicalTrials.gov, 1 active, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Trial to Assess Chelation Therapy in Critical Limb Ischemia NCT03982693	Phase 3	Active	Mt. Sinai Medical Center, Miami	50	2019-03-19 → 2027-07
Early Abduction Splintage on Stable Hips in Infants With Developmental Dysplasia of the Hip NCT02885831	—	Completed	University Hospital, Brest	90	2016-12-08 → 2023-01-17
Quantitative Assessment of the Efficacy of Alidya NCT07675356	N/A	Completed	Medical University of Silesia	30	2025-03-01 → 2026-04-30
Comparison of Er-YAG Laser, Air Polishing, and Surgical Excision for Gingival Hyperpigmentation NCT07672587	N/A	Completed	Ondokuz Mayıs University	24	2025-12-01 → 2026-06-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain5 active DMFs3 inactive

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

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.

Products (2)

Sort:

#001 — 44.6MEQ/50ML (0.9MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jun 3, 1986

No patent or exclusivity listings for this strength.

#002 — 50MEQ/50ML (1MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jun 3, 1986