Miacalcin

NDA 20313, held by Saptalis Pharms. Calcitonin Salmon.

As of Nov 13, 2026, NDA 20313 (Miacalcin), held by Saptalis Pharms, was first approved by FDA on Aug 17, 1995, with 22 approved supplements and 0 published complete response letters.

First approved: Aug 17, 1995
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Aug 17, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Miacalcin200 IU/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · spray, metered;nasal	Calcitonin Salmon	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements


Sep 12, 2017	Supplement 36Labeling · Standard review	Approved	Letter Label
Mar 11, 2014	Supplement 34Labeling	Approved	Label Letter
Feb 27, 2014	Supplement 35Manufacturing · Standard review	Approved	None posted
Apr 18, 2012	Supplement 33Labeling · Standard review	Approved	Letter Label
Oct 30, 2009	Supplement 29Labeling · Standard review	Approved	Label
Jan 6, 2006	Supplement 21Labeling · Standard review	Approved	Letter
Aug 22, 2003	Supplement 23Manufacturing · Standard review	Approved	Review Letter
May 10, 2002	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 2, 2001	Supplement 18Manufacturing · Standard review	Approved	None posted
Jul 14, 2000	Supplement 17Manufacturing · Standard review	Approved	None posted
Jul 23, 1999	Supplement 15Manufacturing · Standard review	Approved	None posted
Jan 13, 1999	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 24, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 17, 1998	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 14, 1998	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 12, 1998	Supplement 10Labeling · Standard review	Approved	None posted
Sep 15, 1997	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 1, 1997	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 24, 1997	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 27, 1997	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 7, 1997	Supplement 3Labeling · Standard review	Approved	None posted
Oct 22, 1996	Supplement 2Labeling · Standard review	Approved	None posted
Aug 17, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20313
Drugs@FDA: Overview at FDA
Company: Saptalis Pharmaceuticals

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