Strontium Chloride Sr-89

ANDA 75941, held by Q Biomed. Strontium Chloride Sr-89.

As of Nov 15, 2026, ANDA 75941 (Strontium Chloride Sr-89), held by Q Biomed, was first approved by FDA on Jan 6, 2003, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 6, 2003
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 6, 2003	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Strontium Chloride Sr-891mCi/ML · injectable;injection	Strontium Chloride Sr-89	Rx

All 2 submissions, including labeling and manufacturing supplements


Jul 11, 2013	Supplement 11Manufacturing	Approved	None posted
Jan 6, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 75941
Drugs@FDA: Overview at FDA
Company: Q BioMed

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