Sodium Bicarbonate

ANDA 202679, held by Hospira. Sodium Bicarbonate.

As of Nov 15, 2026, ANDA 202679 (Sodium Bicarbonate), held by Hospira, was first approved by FDA on Mar 7, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 7, 2017
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 7, 2017	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sodium Bicarbonate5MEQ/10ML (0.5MEQ/ML) · solution;intravenous	Sodium Bicarbonate	Rx

All 3 submissions, including labeling and manufacturing supplements


Jun 14, 2021	Supplement 10Manufacturing	Approved	None posted
Aug 29, 2017	Supplement 2Labeling · Standard review	Approved	None posted
Mar 7, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 202679
Drugs@FDA: Overview at FDA
Company: Hospira

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters