Procalamine

NDA 18582, held by B Braun. Amino Acids; Calcium Acetate; Glycerin; Magnesium Acetate; Phosphoric Acid; Potassium Chloride; Sodium Acetate; Sodium Chloride.

As of Nov 13, 2026, NDA 18582 (Procalamine), held by B Braun, was first approved by FDA on May 6, 1982, with 26 approved supplements and 0 published complete response letters.

First approved: May 6, 1982
Review: Standard
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
May 6, 1982	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Procalamine3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML · injectable;injection	Amino Acids; Calcium Acetate; Glycerin; Magnesium Acetate; Phosphoric Acid; Potassium Chloride; Sodium Acetate; Sodium Chloride	Discontinued

All 27 submissions, including labeling and manufacturing supplements


Aug 21, 2013	Supplement 47Manufacturing · Standard review	Approved	None posted
Mar 19, 2013	Supplement 42Manufacturing · Standard review	Approved	None posted
Dec 24, 2003	Supplement 31Manufacturing · Standard review	Approved	Label Letter
Jun 20, 2000	Supplement 30Manufacturing · Standard review	Approved	None posted
Apr 12, 2000	Supplement 29Manufacturing · Standard review	Approved	None posted
May 4, 1999	Supplement 28Manufacturing · Standard review	Approved	None posted
Jun 14, 1996	Supplement 27Manufacturing · Standard review	Approved	None posted
Sep 13, 1995	Supplement 26Manufacturing · Standard review	Approved	None posted
Oct 28, 1994	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 8, 1993	Supplement 23Manufacturing · Standard review	Approved	None posted
Sep 28, 1992	Supplement 22Manufacturing · Standard review	Approved	None posted
Dec 11, 1991	Supplement 21Manufacturing · Standard review	Approved	None posted
Apr 11, 1990	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 11, 1988	Supplement 9Labeling	Approved	None posted
Mar 7, 1988	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 8, 1987	Supplement 17Labeling	Approved	None posted
Jul 9, 1987	Supplement 16Labeling	Approved	None posted
Nov 13, 1986	Supplement 14Manufacturing · Standard review	Approved	None posted
May 21, 1986	Supplement 12Labeling	Approved	None posted
Sep 10, 1985	Supplement 5Labeling	Approved	None posted
Sep 10, 1985	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 27, 1985	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 14, 1985	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 26, 1982	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 19, 1982	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 1, 1982	Supplement 3Manufacturing · Standard review	Approved	None posted
May 6, 1982	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18582
Drugs@FDA: Overview at FDA
Company: B. Braun Medical

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