Dtic-Dome

NDA 17575, held by Bayer Hlthcare. Dacarbazine.

As of Nov 13, 2026, NDA 17575 (Dtic-Dome), held by Bayer Hlthcare, was first approved by FDA on May 27, 1975, with 13 approved supplements and 0 published complete response letters.

First approved: May 27, 1975
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Apr 29, 1981	Supplement 3Efficacy (new indication or use)	Approved	None posted
May 27, 1975	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


Dtic-Dome100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Dacarbazine	DiscontinuedReference drug
Dtic-Dome200MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Dacarbazine	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements


Sep 24, 1998	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 7, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
May 24, 1996	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 29, 1991	Supplement 16Manufacturing · Standard review	Approved	None posted
Apr 19, 1989	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 2, 1988	Supplement 12Manufacturing · Standard review	Approved	None posted
May 22, 1986	Supplement 9Labeling	Approved	None posted
Jul 15, 1985	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 5, 1983	Supplement 7Labeling	Approved	None posted
Apr 29, 1981	Supplement 3Efficacy (new indication or use)	Approved	None posted
Oct 27, 1980	Supplement 4Manufacturing · Standard review	Approved	None posted
May 24, 1979	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 10, 1975	Supplement 1Manufacturing · Standard review	Approved	None posted
May 27, 1975	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 17575
Drugs@FDA: Overview at FDA
Company: Bayer Healthcare

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