Diflucan In Sodium Chloride 0.9%, Diflucan In Sodium Chloride 0.9% In Plastic Container, Diflucan In Dextrose 5% In Plastic Container

NDA 19950, held by Pfizer. Fluconazole.

As of Nov 14, 2026, NDA 19950 (Diflucan In Sodium Chloride 0.9%, Diflucan In Sodium Chloride 0.9% In Plastic Container, Diflucan In Dextrose 5% In Plastic Container), held by Pfizer, was first approved by FDA on Jan 29, 1990, with 46 approved supplements and 0 published complete response letters.

First approved: Jan 29, 1990
Review: Standard
Supplements approved: 46
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 47 submissions below


Nov 23, 1994	Supplement 16Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 30, 1993	Supplement 4Efficacy (new indication or use)	Approved	None posted
Jan 29, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Products

6 strengths and forms


Diflucan In Sodium Chloride 0.9%200MG/100ML (2MG/ML) · injectable;injection	Fluconazole	DiscontinuedReference drug
Diflucan In Sodium Chloride 0.9% In Plastic Container200MG/100ML (2MG/ML) · injectable;injection	Fluconazole	DiscontinuedReference drug
Diflucan In Dextrose 5% In Plastic Container200MG/100ML (2MG/ML) · injectable;injection	Fluconazole	DiscontinuedReference drug
Diflucan In Sodium Chloride 0.9% In Plastic Container400MG/200ML (2MG/ML) · injectable;injection	Fluconazole	DiscontinuedReference drug
Diflucan In Dextrose 5% In Plastic Container400MG/200ML (2MG/ML) · injectable;injection	Fluconazole	DiscontinuedReference drug
Diflucan In Sodium Chloride 0.9%400MG/200ML (2MG/ML) · injectable;injection	Fluconazole	DiscontinuedReference drug

All 47 submissions, including labeling and manufacturing supplements


Feb 12, 2024	Supplement 71Labeling · Standard review	Approved	Letter Label
Jul 12, 2023	Supplement 73Labeling · Standard review	Approved	Label Letter
Jan 17, 2023	Supplement 72Labeling · Standard review	Approved	Letter Label
Mar 9, 2022	Supplement 70Labeling · Standard review	Approved	Label Letter
Oct 25, 2021	Supplement 69Labeling · Standard review	Approved	Letter Label
Sep 8, 2020	Supplement 68Labeling · Standard review	Approved	Label Letter
Nov 7, 2019	Supplement 67Labeling · Standard review	Approved	Label Letter
Nov 7, 2019	Supplement 66Labeling · Standard review	Approved	Label Letter
Jun 1, 2015	Supplement 65Manufacturing	Approved	None posted
Jul 28, 2014	Supplement 63Manufacturing	Approved	None posted
Mar 24, 2014	Supplement 62Labeling · Standard review	Approved	Letter Label
Sep 13, 2013	Supplement 61Labeling · Standard review	Approved	Letter Label
Nov 16, 2011	Supplement 59Labeling · Standard review	Approved	Letter Label
Jun 6, 2011	Supplement 56Labeling	Approved	Letter Label
Apr 26, 2011	Supplement 57Labeling	Approved	Letter Label
Aug 5, 2010	Supplement 53Labeling	Approved	Label Letter
Mar 31, 2008	Supplement 43Labeling · Standard review	Approved	Label Letter
Oct 7, 2004	Supplement 37Labeling · Standard review	Approved	Letter Label
Oct 7, 2004	Supplement 33Labeling · Standard review	Approved	Letter Label
Oct 7, 2004	Supplement 31Labeling · Standard review	Approved	Letter Label
Mar 24, 2004	Supplement 39Labeling · Standard review	Approved	Label Letter
Aug 7, 2002	Supplement 34Labeling · Standard review	Approved	None posted
Mar 5, 2001	Supplement 32Manufacturing	Approved	None posted
Sep 29, 1999	Supplement 30Manufacturing	Approved	None posted
Sep 29, 1999	Supplement 29Manufacturing	Approved	None posted
Feb 22, 1999	Supplement 28Labeling · Standard review	Approved	None posted
Feb 13, 1998	Supplement 27Manufacturing	Approved	None posted
Aug 5, 1997	Supplement 26Labeling · Standard review	Approved	None posted
Feb 19, 1997	Supplement 25Labeling · Standard review	Approved	None posted
Aug 6, 1996	Supplement 24Labeling · Standard review	Approved	None posted
Jul 23, 1996	Supplement 22Labeling · Standard review	Approved	None posted
Dec 22, 1995	Supplement 21Manufacturing	Approved	None posted
Mar 20, 1995	Supplement 20Manufacturing	Approved	None posted
Mar 9, 1995	Supplement 19Manufacturing	Approved	None posted
Nov 23, 1994	Supplement 16Efficacy (new indication or use) · Standard review	Approved	None posted
Aug 22, 1994	Supplement 17Manufacturing	Approved	None posted
Jul 8, 1994	Supplement 12Manufacturing	Approved	None posted
Jun 30, 1994	Supplement 18Labeling · Standard review	Approved	None posted
Dec 30, 1993	Supplement 4Efficacy (new indication or use)	Approved	None posted
Oct 13, 1993	Supplement 3Labeling	Approved	None posted
Oct 13, 1993	Supplement 7Labeling	Approved	None posted
Oct 13, 1993	Supplement 10Labeling · Standard review	Approved	None posted
Jun 22, 1993	Supplement 11Manufacturing	Approved	None posted
Jun 14, 1993	Supplement 8Manufacturing	Approved	None posted
Feb 10, 1993	Supplement 9Manufacturing	Approved	None posted
Sep 29, 1992	Supplement 2Manufacturing	Approved	None posted
Jan 29, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19950
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