Trobicin

NDA 50347, held by Pfizer. Spectinomycin Hydrochloride.

As of Nov 14, 2026, NDA 50347 (Trobicin), held by Pfizer, was first approved by FDA on Jun 30, 1971, with 38 approved supplements and 0 published complete response letters.

First approved: Jun 30, 1971
Supplements approved: 38
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 39 submissions below

Date	Submission	Status	Documents
Jun 30, 1971	Original application	Approved	None posted

Products

2 strengths and forms


TrobicinEQ 2GM BASE/VIAL · injectable;injection	Spectinomycin Hydrochloride	Discontinued
TrobicinEQ 4GM BASE/VIAL · injectable;injection	Spectinomycin Hydrochloride	Discontinued

All 39 submissions, including labeling and manufacturing supplements


Aug 15, 2012	Supplement 60Labeling · Standard review	Approved	Letter Label
Nov 15, 2011	Supplement 58Labeling · Standard review	Approved	Letter Label
Aug 19, 2004	Supplement 52Labeling · Standard review	Approved	Letter
May 15, 2002	Supplement 49Manufacturing	Approved	None posted
Sep 21, 2001	Supplement 48Manufacturing	Approved	None posted
Jul 17, 2001	Supplement 47Manufacturing	Approved	None posted
Aug 1, 1996	Supplement 46Manufacturing	Approved	None posted
Aug 1, 1996	Supplement 45Manufacturing	Approved	None posted
Sep 27, 1995	Supplement 44Labeling	Approved	None posted
Aug 26, 1991	Supplement 8Manufacturing	Approved	None posted
Aug 23, 1991	Supplement 7Manufacturing	Approved	None posted
Mar 22, 1990	Supplement 6Manufacturing	Approved	None posted
Oct 30, 1981	Supplement 43Manufacturing	Approved	None posted
May 8, 1980	Supplement 41Labeling	Approved	None posted
Sep 10, 1979	Supplement 38Manufacturing	Approved	None posted
Apr 10, 1979	Supplement 36Manufacturing	Approved	None posted
Apr 10, 1979	Supplement 35Labeling	Approved	None posted
Mar 9, 1979	Supplement 37Labeling	Approved	None posted
Jul 13, 1978	Supplement 34Manufacturing	Approved	None posted
Jul 26, 1977	Supplement 33Manufacturing	Approved	None posted
Nov 4, 1976	Supplement 32Manufacturing	Approved	None posted
Aug 3, 1976	Supplement 31Labeling	Approved	None posted
Sep 12, 1975	Supplement 30Labeling	Approved	None posted
Jul 8, 1975	Supplement 28Labeling	Approved	None posted
Jun 3, 1975	Supplement 29Labeling	Approved	None posted
Dec 24, 1974	Supplement 26Labeling	Approved	None posted
May 23, 1974	Supplement 25Labeling	Approved	None posted
Jun 18, 1973	Supplement 24Labeling	Approved	None posted
Mar 9, 1973	Supplement 23Labeling	Approved	None posted
Dec 5, 1972	Supplement 22Labeling	Approved	None posted
Oct 24, 1972	Supplement 21Labeling	Approved	None posted
Aug 21, 1972	Supplement 20Labeling	Approved	None posted
Apr 10, 1972	Supplement 19Labeling	Approved	None posted
Feb 25, 1972	Supplement 18Labeling	Approved	None posted
Oct 4, 1971	Supplement 17Labeling	Approved	None posted
Sep 10, 1971	Supplement 16Labeling	Approved	None posted
Aug 19, 1971	Supplement 15Labeling	Approved	None posted
Jul 6, 1971	Supplement 14Labeling	Approved	None posted
Jun 30, 1971	Original application	Approved	None posted

Identifiers

Application: NDA 50347
Drugs@FDA: Overview at FDA
Company: Pfizer

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