Details for New Drug Application (NDA): 202679

NDA 202679 describes SODIUM BICARBONATE, which is a drug marketed by Exela Pharma, Hospira, Intl Medication Sys, Long Grove Pharms, Omnivium Pharms, Steriscience, and Abbott, and is included in twelve NDAs. It is available from sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the sodium bicarbonate profile page.

Summary for 202679

Tradename:	SODIUM BICARBONATE
Applicant:	Hospira
Ingredient:	sodium bicarbonate
Patents:	0

Pharmacology for NDA: 202679

Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Suppliers and Packaging for NDA: 202679

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM BICARBONATE	sodium bicarbonate	INJECTABLE;INJECTION	202679	ANDA	Henry Schein, Inc.	0404-9985	0404-9985-10	1 SYRINGE in 1 BAG (0404-9985-10) / 10 mL in 1 SYRINGE
SODIUM BICARBONATE	sodium bicarbonate	INJECTABLE;INJECTION	202679	ANDA	Hospira, Inc.	0409-5534	0409-5534-14	10 CARTON in 1 PACKAGE (0409-5534-14) / 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE (0409-5534-24)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.5MEQ/ML
Approval Date:	Mar 7, 2017	TE:	AP	RLD:	No

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