Elase-Chloromycetin

BLA 50294, held by Parke Davis. Chloramphenicol; Desoxyribonuclease; Fibrinolysin.

As of Nov 13, 2026, BLA 50294 (Elase-Chloromycetin), held by Parke Davis, was first approved by FDA on Apr 1, 1964, with 22 approved supplements and 0 published complete response letters.

First approved: Apr 1, 1964
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
Apr 1, 1964	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Elase-Chloromycetin10MG/GM;666 UNITS/GM;1 UNITS/GM · ointment;topical	Chloramphenicol; Desoxyribonuclease; Fibrinolysin	Discontinued

All 23 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 8, 1998	Supplement 24Manufacturing	Approved	None posted
Apr 23, 1997	Supplement 22Manufacturing	Approved	None posted
Nov 6, 1990	Supplement 10Labeling	Approved	None posted
Apr 21, 1988	Supplement 4Labeling	Approved	None posted
Sep 26, 1986	Supplement 3Manufacturing	Approved	None posted
Jul 22, 1983	Supplement 2Manufacturing	Approved	None posted
Apr 19, 1983	Supplement 1Manufacturing	Approved	None posted
Sep 25, 1980	Supplement 21Labeling	Approved	None posted
Dec 20, 1979	Supplement 20Manufacturing	Approved	None posted
Sep 14, 1978	Supplement 19Labeling	Approved	None posted
Jun 6, 1978	Supplement 18Manufacturing	Approved	None posted
Jun 5, 1978	Supplement 17Manufacturing	Approved	None posted
Jun 5, 1978	Supplement 16Manufacturing	Approved	None posted
Feb 23, 1977	Supplement 15Manufacturing	Approved	None posted
Jun 25, 1975	Supplement 14Manufacturing	Approved	None posted
Oct 11, 1974	Supplement 13Manufacturing	Approved	None posted
May 21, 1973	Supplement 12Labeling	Approved	None posted
Dec 13, 1971	Supplement 11Labeling	Approved	None posted
Jan 21, 1970	Supplement 9Labeling	Approved	None posted
Apr 24, 1967	Supplement 8Labeling	Approved	None posted
Apr 14, 1964	Supplement 5Labeling	Approved	None posted
Apr 14, 1964	Supplement 6Labeling	Approved	None posted
Apr 1, 1964	Original application	Approved	None posted

Identifiers

Application: BLA 50294
Drugs@FDA: Overview at FDA
Company: Parke-Davis

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