Banan

NDA 50688, held by Sankyo. Cefpodoxime Proxetil.

As of Nov 14, 2026, NDA 50688 (Banan), held by Sankyo, was first approved by FDA on Aug 7, 1992, with 13 approved supplements and 0 published complete response letters.

First approved: Aug 7, 1992
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Feb 10, 2000	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Feb 10, 2000	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Review Letter
Feb 10, 2000	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Label Letter Review
Feb 10, 2000	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 22, 1997	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Jun 16, 1995	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Aug 7, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


BananEQ 100MG BASE/5ML · for suspension;oral	Cefpodoxime Proxetil	Discontinued
BananEQ 50MG BASE/5ML · for suspension;oral	Cefpodoxime Proxetil	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Feb 10, 2000	Supplement 13Labeling · Standard review	Approved	Letter Label Review
Feb 10, 2000	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Feb 10, 2000	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Review Letter
Feb 10, 2000	Supplement 10Labeling · Standard review	Approved	Letter Label Review
Feb 10, 2000	Supplement 9Labeling · Standard review	Approved	Review Letter Label
Feb 10, 2000	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Label Letter Review
Feb 10, 2000	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
May 27, 1999	Supplement 7Labeling · Standard review	Approved	None posted
May 26, 1999	Supplement 5Labeling · Standard review	Approved	None posted
Dec 22, 1997	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Jun 16, 1995	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Oct 12, 1993	Supplement 2Labeling · Standard review	Approved	None posted
Apr 8, 1993	Supplement 3Labeling · Standard review	Approved	None posted
Aug 7, 1992	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50688
Drugs@FDA: Overview at FDA
Company: Sankyo

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