Spectrobid

NDA 50520, held by Pfizer. Bacampicillin Hydrochloride.

As of Nov 14, 2026, NDA 50520 (Spectrobid), held by Pfizer, was first approved by FDA on Dec 22, 1980, with 10 approved supplements and 0 published complete response letters.

First approved: Dec 22, 1980
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Dec 22, 1980	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


Spectrobid400MG · tablet;oral	Bacampicillin Hydrochloride	Discontinued
Spectrobid800MG · tablet;oral	Bacampicillin Hydrochloride	Discontinued

All 11 submissions, including labeling and manufacturing supplements


May 29, 1992	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 12, 1983	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 12, 1983	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 2, 1983	Supplement 3Labeling · Standard review	Approved	None posted
Dec 29, 1982	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 23, 1982	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 27, 1982	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 23, 1981	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 7, 1981	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 14, 1981	Supplement 6Labeling · Standard review	Approved	None posted
Dec 22, 1980	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 50520
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