Microlite

BLA 18263, held by Pharmalucence. Technetium Tc-99m Albumin Colloid Kit.

As of Nov 13, 2026, BLA 18263 (Microlite), held by Pharmalucence, was first approved by FDA on Mar 25, 1983, with 8 approved supplements and 0 published complete response letters.

First approved: Mar 25, 1983
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Mar 25, 1983	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
MicroliteN/A · injectable;injection	Technetium Tc-99m Albumin Colloid Kit	Discontinued

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 2, 1989	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 26, 1989	Supplement 10Labeling	Approved	None posted
Mar 17, 1989	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 24, 1987	Supplement 8Labeling	Approved	None posted
Aug 26, 1987	Supplement 4Manufacturing · Standard review	Approved	None posted
May 6, 1986	Supplement 5Labeling	Approved	None posted
Jul 18, 1984	Supplement 2Manufacturing · Standard review	Approved	None posted
May 31, 1983	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 25, 1983	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: BLA 18263
Drugs@FDA: Overview at FDA
Company: Pharmalucence

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters