FDA Drug Application 016515 by MALLINKRODT NUCLEAR

Application Number	016515
Application Type	New Drug Application
Sponsor Applicant	MALLINKRODT NUCLEAR
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New manufacturer
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	8/18/1971	N
AP	6/2/1976	SLR
AP	10/27/1977	SCS
AP	10/27/1977	SLR
AP	7/27/1977	SCM
AP	6/7/1988	SCF
AP	7/11/1983	SPD
AP	2/3/2012	SLR	31665	010	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016515s010lbl.pdf	2/6/2012
AP	2/3/2012	SLR	31705	010	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016515s010ltr.pdf	2/7/2012
AP	3/20/2014	SLR	38868	012	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016515Orig1s012ltr.pdf	3/21/2014
AP	3/20/2014	SLR	38888	012	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016515s012lbl.pdf	3/25/2014
AP	10/20/2015	SLR	44239	013	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016515Orig1s013ltr.pdf	10/21/2015
AP	10/20/2015	SLR	44255	013	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016515s013lbl.pdf	10/22/2015

Back to FDA Applications sponsored by MALLINKRODT NUCLEAR