Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 006695
Company: RECORDATI RARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MUSTARGEN MECHLORETHAMINE HYDROCHLORIDE 10MG/VIAL INJECTABLE;INJECTION Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/15/1949 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/09/2004 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/06695slr031_mustargen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/06695slr031ltr.pdf
03/19/2003 SUPPL-30 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06695slr030ltr.pdf
11/17/2000 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/2000 SUPPL-28 Labeling

Label is not available on this site.

10/16/1998 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/1998 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/1995 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/10/1995 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/1995 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1994 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1995 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1987 SUPPL-20 Labeling

Label is not available on this site.

01/15/1987 SUPPL-19 Labeling

Label is not available on this site.

03/29/1986 SUPPL-17 Labeling

Label is not available on this site.

02/21/1983 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/04/1982 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/1980 SUPPL-14 Labeling

Label is not available on this site.

06/12/1978 SUPPL-13 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/09/2004 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/06695slr031_mustargen_lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English