Details for New Drug Application (NDA): 203449

NDA 203449 describes SODIUM BICARBONATE, which is a drug marketed by Exela Pharma, Fresenius Kabi Usa, Hospira, Intl Medication Sys, Long Grove Pharms, Neocubes Pharma, Omnivium Pharms, Steriscience, and Abbott, and is included in fourteen NDAs. It is available from nineteen suppliers. Additional details are available on the SODIUM BICARBONATE profile page.

The generic ingredient in SODIUM BICARBONATE is sodium bicarbonate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the sodium bicarbonate profile page.

Summary for 203449

Tradename:	SODIUM BICARBONATE
Applicant:	Intl Medication Sys
Ingredient:	sodium bicarbonate
Patents:	0

Pharmacology for NDA: 203449

Mechanism of Action

Alkalinizing Activity

Suppliers and Packaging for NDA: 203449

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM BICARBONATE	sodium bicarbonate	SOLUTION;INTRAVENOUS	203449	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1383	51662-1383-1	1 SYRINGE in 1 CARTON (51662-1383-1) / 50 mL in 1 SYRINGE
SODIUM BICARBONATE	sodium bicarbonate	SOLUTION;INTRAVENOUS	203449	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1383	51662-1383-3	10 POUCH in 1 CASE (51662-1383-3) / 1 SYRINGE in 1 POUCH (51662-1383-2) / 50 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	50MEQ/50ML (1MEQ/ML)
Approval Date:	Sep 19, 2017	TE:	AP	RLD:	No

Complete Access Available with Subscription