FDA Drug Application 016949 by HERITAGE PHARMS INC

Application Number	016949
Application Type	New Drug Application
Sponsor Applicant	HERITAGE PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New combination
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	12/23/1977	N	16514	000	http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273	5/9/2007
AP	12/23/1977	N	24008	000	http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088622.pdf	11/19/2009
AP	9/9/1980	SCP
AP	9/9/1980	SCS
AP	9/9/1980	SCS
AP	4/17/1978	SCF
AP	7/24/1978	SCM
AP	8/22/1978	SCP
AP	9/7/1979	SCM
AP	9/25/1978	SLR
AP	8/15/1979	SCM
AP	1/21/1980	SCF
AP	5/19/1980	SCF
AP	3/28/1980	SLR
AP	5/19/1980	SCF
AP	3/22/1982	SCM
AP	9/20/1982	SCS
AP	9/20/1982	SCS
AP	6/26/1984	SCS
AP	4/17/1985	SLR
AP	11/19/1985	SLR
AP	6/9/1988	SCS
AP	3/28/2000	SLR
AP	1/16/1990	SCP
AP	12/28/1992	SCS
AP	3/28/2000	SLR
AP	3/28/2000	SLR
AP	6/5/2001	SLR	3405	033	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16949s33ltr.pdf	6/5/2001
AP	12/19/2001	SCM
AP	1/12/2005	SLR	10968	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16949s035ltr.pdf	1/13/2005
AP	1/12/2005	SLR	10988	035	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16949s035lbl.pdf	1/13/2005
AP	8/3/2007	SLR	17503	038	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016949s038lbl.pdf	8/6/2007
AP	8/3/2007	SLR	17571	038	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016949s038ltr.pdf	8/7/2007
AP	4/25/2016	SLR	45762	039	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016949Orig1s039ltr.pdf	4/27/2016
AP	4/25/2016	SLR	45773	039	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s039lbl.pdf	4/27/2016

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