Back to FDA Applications sponsored by ANI PHARMS INC

FDA Drug Application 018553 by ANI PHARMS INC

Application Number	018553
Application Type	New Drug Application
Sponsor Applicant	ANI PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	4/19/1983	N
AP	1/9/1984	SES
AP	3/6/1984	SCM
AP	10/11/1984	SCS
AP	8/9/1984	SCE	23312	005	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s005_INDERAL LA.pdf	9/14/2009
AP	3/21/1985	SLR	23313	006	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s006_INDERAL LA.pdf	9/14/2009
AP	8/20/1985	SES
AP	1/7/1986	SCS
AP	4/2/1985	SCM
AP	11/20/1985	SCS
AP	3/4/1986	SCM	23314	012	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s012_INDERAL LA.pdf	9/14/2009
AP	3/18/1987	SE2	23315	013	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s013_INDERAL LA.pdf	9/14/2009
AP	5/27/1986	SCF	23316	015	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s015_INDERAL LA.pdf	9/14/2009
AP	9/2/1986	SCS
AP	1/20/1987	SCP
AP	5/25/1988	SCP
AP	8/8/1988	SCS
AP	1/25/1989	SCP
AP	4/10/1989	SCS
AP	6/5/1989	SCM
AP	7/10/1989	SCE
AP	2/9/1990	SCF
AP	4/17/1990	SCS
AP	11/7/1997	SLR
AP	8/22/1999	SLR
AP	3/31/2000	SCM
AP	2/6/2002	SLR
AP	6/9/2004	SLR	9312	030	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18553slr030ltr.pdf	6/10/2004
AP	1/3/2007	SLR	15585	034	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s034ltr.pdf	1/8/2007
AP	2/21/2007	SLR	15952	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s035ltr.pdf	3/6/2007
AP	10/31/2007	SLR	18369	036	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s036ltr.pdf	11/8/2007
AP	3/17/2011	SLR	28302	037	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018553s037lbl.pdf	3/21/2011
AP	3/17/2011	SLR	28311	037	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018553s037ltr.pdf	3/23/2011
AP	10/22/2015	SCM
AP	12/21/2015	SCM

Back to FDA Applications sponsored by ANI PHARMS INC