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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 006695
Company: RECORDATI RARE

Products on NDA 006695

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 006695

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.

Labels for NDA 006695

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

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