Calcimar

NDA 17769, held by Sanofi Aventis US. Calcitonin Salmon.

As of Nov 14, 2026, NDA 17769 (Calcimar), held by Sanofi Aventis US, was first approved by FDA on Apr 17, 1978, with 21 approved supplements and 0 published complete response letters.

First approved: Apr 17, 1978
Review: Standard
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Apr 17, 1978	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Calcimar200 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Calcitonin Salmon	DiscontinuedReference drug

All 22 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 12Labeling	Approved	None posted
Dec 7, 2007	Supplement 10Labeling	Approved	None posted
Dec 7, 2007	Supplement 8Labeling	Approved	None posted
May 16, 1996	Supplement 27Manufacturing · Standard review	Approved	None posted
Sep 24, 1993	Supplement 24Labeling	Approved	None posted
Jul 12, 1993	Supplement 23Manufacturing · Standard review	Approved	None posted
Jul 6, 1993	Supplement 25Labeling · Standard review	Approved	None posted
Jun 1, 1992	Supplement 21Labeling	Approved	None posted
May 6, 1992	Supplement 22Labeling	Approved	None posted
Apr 8, 1991	Supplement 20Labeling	Approved	None posted
Apr 4, 1991	Supplement 19Manufacturing · Standard review	Approved	None posted
Mar 21, 1990	Supplement 18Manufacturing · Standard review	Approved	None posted
Jul 6, 1989	Supplement 17Labeling	Approved	None posted
Mar 22, 1988	Supplement 16Labeling	Approved	None posted
Aug 8, 1986	Supplement 14Manufacturing · Standard review	Approved	None posted
May 10, 1984	Supplement 13Manufacturing · Standard review	Approved	None posted
Nov 26, 1979	Supplement 2Labeling	Approved	None posted
May 4, 1979	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 6, 1979	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 10, 1979	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 14, 1978	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 17, 1978	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17769
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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