Calcibind

NDA 18757, held by Mission Pharma. Cellulose Sodium Phosphate.

As of Nov 13, 2026, NDA 18757 (Calcibind), held by Mission Pharma, was first approved by FDA on Dec 28, 1982, with 9 approved supplements and 0 published complete response letters.

First approved: Dec 28, 1982
Review: Priority
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Dec 28, 1982	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Calcibind2.5GM/PACKET · powder;oral	Cellulose Sodium Phosphate	Discontinued
Calcibind300GM/BOT · powder;oral	Cellulose Sodium Phosphate	Discontinued

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 5, 2002	Supplement 10Manufacturing · Priority review	Approved	None posted
Jul 30, 1999	Supplement 8Manufacturing · Priority review	Approved	None posted
May 28, 1999	Supplement 7Manufacturing · Priority review	Approved	None posted
Feb 11, 1999	Supplement 6Manufacturing · Priority review	Approved	None posted
Jun 14, 1996	Supplement 5Manufacturing · Priority review	Approved	None posted
Dec 23, 1988	Supplement 4Manufacturing · Priority review	Approved	None posted
Jul 8, 1988	Supplement 3Labeling	Approved	None posted
Oct 16, 1984	Supplement 2Labeling	Approved	None posted
Apr 10, 1984	Supplement 1Manufacturing · Priority review	Approved	None posted
Dec 28, 1982	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 18757
Drugs@FDA: Overview at FDA
Company: Mission Pharma

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