Fortaz In Plastic Container

NDA 50634, held by Pai Holdings Pharm. Ceftazidime Sodium.

As of Nov 13, 2026, NDA 50634 (Fortaz In Plastic Container), held by Pai Holdings Pharm, was first approved by FDA on Apr 28, 1989, with 21 approved supplements and 0 published complete response letters.

First approved: Apr 28, 1989
Review: Standard
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Apr 28, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


Fortaz In Plastic ContainerEQ 10MG BASE/ML · injectable;injection	Ceftazidime Sodium	Discontinued
Fortaz In Plastic ContainerEQ 20MG BASE/ML · injectable;injection	Ceftazidime Sodium	DiscontinuedReference drug
Fortaz In Plastic ContainerEQ 40MG BASE/ML · injectable;injection	Ceftazidime Sodium	DiscontinuedReference drug

All 22 submissions, including labeling and manufacturing supplements


Jul 28, 2017	Supplement 28Labeling · Standard review	Approved	Letter Label
Sep 24, 2014	Supplement 23Labeling · Standard review	Approved	Letter Label
Apr 11, 2014	Supplement 27Manufacturing · Standard review	Approved	None posted
Apr 29, 2013	Supplement 26Manufacturing · Standard review	Approved	None posted
Jul 9, 2007	Supplement 20Labeling · Standard review	Approved	Letter Label
Mar 14, 2007	Supplement 18Labeling · Standard review	Approved	Letter Label
May 19, 2004	Supplement 16Labeling · Standard review	Approved	Label Letter
Mar 29, 2002	Supplement 12Labeling · Standard review	Approved	Label Letter
Mar 22, 2002	Supplement 14Labeling · Standard review	Approved	Letter
Feb 22, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
Jan 26, 1998	Supplement 6Labeling · Standard review	Approved	None posted
Nov 25, 1997	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 24, 1996	Supplement 10Labeling · Standard review	Approved	None posted
Sep 11, 1996	Supplement 9Labeling · Standard review	Approved	None posted
Aug 20, 1996	Supplement 5Labeling · Standard review	Approved	None posted
Jun 20, 1996	Supplement 8Labeling · Standard review	Approved	None posted
Jun 20, 1996	Supplement 7Labeling · Standard review	Approved	None posted
Oct 20, 1994	Supplement 4Labeling	Approved	None posted
Sep 7, 1994	Supplement 1Labeling	Approved	None posted
Nov 8, 1993	Supplement 3Labeling	Approved	None posted
Mar 1, 1993	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 28, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50634
Drugs@FDA: Overview at FDA
Company: PAI Holdings Pharm

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