Zinacef In Plastic Container

NDA 50643, held by Pai Holdings Pharm. Cefuroxime Sodium.

As of Nov 13, 2026, NDA 50643 (Zinacef In Plastic Container), held by Pai Holdings Pharm, was first approved by FDA on Apr 28, 1989, with 18 approved supplements and 0 published complete response letters.

First approved: Apr 28, 1989
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

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

Products

2 strengths and forms

Product	Active ingredient	Marketing
Zinacef In Plastic ContainerEQ 15MG BASE/ML · injectable;injection	Cefuroxime Sodium	Discontinued
Zinacef In Plastic ContainerEQ 30MG BASE/ML · injectable;injection	Cefuroxime Sodium	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 16, 2021	Supplement 27Labeling · Standard review	Approved	Letter Label
Sep 25, 2014	Supplement 22Labeling · Standard review	Approved	Label Letter
Apr 29, 2013	Supplement 25Manufacturing · Standard review	Approved	None posted
Jul 30, 2007	Supplement 21Labeling · Standard review	Approved	Letter Label
May 19, 2004	Supplement 15Labeling · Standard review	Approved	Label Letter
Nov 9, 2001	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 12, 2001	Supplement 11Labeling · Standard review	Approved	Label
Jul 12, 2001	Supplement 10Labeling · Standard review	Approved	None posted
Apr 13, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 23, 1996	Supplement 9Labeling · Standard review	Approved	None posted
Dec 23, 1996	Supplement 7Labeling · Standard review	Approved	None posted
Sep 11, 1996	Supplement 8Labeling · Standard review	Approved	None posted
Oct 23, 1995	Supplement 2Labeling	Approved	None posted
Sep 29, 1995	Supplement 6Labeling · Standard review	Approved	None posted
Feb 6, 1995	Supplement 4Labeling · Standard review	Approved	None posted
Oct 27, 1994	Supplement 5Labeling · Standard review	Approved	None posted
Jan 15, 1993	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 30, 1992	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 28, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50643
Drugs@FDA: Overview at FDA
Company: PAI Holdings Pharm

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters