Soyacal 10%

NDA 18465, held by Alpha Thera. Soybean Oil.

As of Nov 14, 2026, NDA 18465 (Soyacal 10%), held by Alpha Thera, was first approved by FDA on Jun 29, 1983, with 14 approved supplements and 0 published complete response letters.

First approved: Jun 29, 1983
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jun 29, 1983	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Soyacal 10%10% · injectable;injection	Soybean Oil	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Nov 7, 1991	Supplement 15Manufacturing · Standard review	Approved	None posted
May 30, 1990	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 27, 1989	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 17, 1989	Supplement 13Manufacturing · Standard review	Approved	None posted
May 20, 1988	Supplement 4Manufacturing · Standard review	Approved	None posted
May 20, 1988	Supplement 5Labeling	Approved	None posted
May 20, 1988	Supplement 11Manufacturing · Standard review	Approved	None posted
May 20, 1988	Supplement 12Labeling	Approved	None posted
Sep 8, 1986	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 8, 1986	Supplement 9Labeling	Approved	None posted
Dec 11, 1985	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 11, 1985	Supplement 7Labeling	Approved	None posted
Jun 25, 1985	Supplement 3Labeling	Approved	None posted
Aug 2, 1984	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 29, 1983	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18465
Drugs@FDA: Overview at FDA
Company: Alpha Thera

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