Albamycin

NDA 50339, held by Pharmacia And Upjohn. Novobiocin Sodium.

As of Nov 13, 2026, NDA 50339 (Albamycin), held by Pharmacia And Upjohn, was first approved by FDA on Sep 4, 1964, with 37 approved supplements and 0 published complete response letters.

First approved: Sep 4, 1964
Supplements approved: 37
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 38 submissions below

Date	Submission	Status	Documents
Sep 4, 1964	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
AlbamycinEQ 250MG BASE · capsule; oral	Novobiocin Sodium	Discontinued

All 38 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 17, 1983	Supplement 1Manufacturing	Approved	None posted
Aug 24, 1982	Supplement 37Manufacturing	Approved	None posted
Jun 24, 1982	Supplement 36Labeling	Approved	None posted
Feb 22, 1982	Supplement 35Manufacturing	Approved	None posted
Apr 27, 1979	Supplement 34Labeling	Approved	None posted
Apr 3, 1979	Supplement 33Manufacturing	Approved	None posted
Mar 24, 1978	Supplement 32Manufacturing	Approved	None posted
Nov 24, 1976	Supplement 31Manufacturing	Approved	None posted
Apr 1, 1975	Supplement 30Manufacturing	Approved	None posted
Nov 26, 1974	Supplement 29Labeling	Approved	None posted
Jun 8, 1973	Supplement 28Manufacturing	Approved	None posted
Jun 8, 1973	Supplement 27Labeling	Approved	None posted
May 4, 1972	Supplement 26Labeling	Approved	None posted
Dec 17, 1971	Supplement 25Labeling	Approved	None posted
Oct 12, 1970	Supplement 24Manufacturing	Approved	None posted
Jul 21, 1970	Supplement 23Labeling	Approved	None posted
Apr 20, 1970	Supplement 22Labeling	Approved	None posted
Mar 27, 1970	Supplement 21Labeling	Approved	None posted
Mar 27, 1970	Supplement 19Manufacturing	Approved	None posted
Feb 10, 1970	Supplement 20Manufacturing	Approved	None posted
Nov 26, 1969	Supplement 18Labeling	Approved	None posted
Nov 14, 1969	Supplement 17Manufacturing	Approved	None posted
Oct 6, 1969	Supplement 16Labeling	Approved	None posted
Aug 5, 1969	Supplement 14Labeling	Approved	None posted
Jun 30, 1969	Supplement 15Labeling	Approved	None posted
Jun 5, 1969	Supplement 13Manufacturing	Approved	None posted
Mar 14, 1969	Supplement 12Manufacturing	Approved	None posted
Aug 8, 1968	Supplement 11Manufacturing	Approved	None posted
Aug 7, 1967	Supplement 10Labeling	Approved	None posted
Mar 20, 1967	Supplement 9Labeling	Approved	None posted
Dec 15, 1966	Supplement 8Labeling	Approved	None posted
Nov 25, 1966	Supplement 7Manufacturing	Approved	None posted
Sep 19, 1966	Supplement 6Labeling	Approved	None posted
Feb 25, 1966	Supplement 5Labeling	Approved	None posted
Jan 22, 1965	Supplement 4Labeling	Approved	None posted
Nov 6, 1964	Supplement 3Labeling	Approved	None posted
Oct 8, 1964	Supplement 2Manufacturing	Approved	None posted
Sep 4, 1964	Original application	Approved	None posted

Identifiers

Application: NDA 50339
Drugs@FDA: Overview at FDA
Company: Pharmacia & Upjohn

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