Diltiazem Hydrochloride

ANDA 75853, held by Hospira. Diltiazem Hydrochloride.

First approved: Dec 17, 2002
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 17, 2002	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diltiazem Hydrochloride100MG/VIAL · injectable;injection	Diltiazem Hydrochloride	Rx

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 13, 2017	Supplement 9Labeling · Standard review	Approved	None posted
Jan 3, 2007	Supplement 3Labeling	Approved	None posted
Dec 17, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 75853
Drugs@FDA: Overview at FDA
Company: Hospira

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