Dexamethasone Sodium Phosphate Preservative Free

ANDA 40491, held by Fresenius Kabi USA. Dexamethasone Sodium Phosphate.

First approved: Apr 11, 2003
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 11, 2003	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dexamethasone Sodium Phosphate Preservative FreeEQ 10MG PHOSPHATE/ML · injectable;injection	Dexamethasone Sodium Phosphate	Rx

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 5, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Aug 6, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Jul 3, 2014	Supplement 8Labeling · Standard review	Approved	Letter Label
Jun 9, 2005	Supplement 2Labeling	Approved	None posted
Apr 11, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 40491
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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