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Back to FDA Applications sponsored by PERRIGO PHARMA INTL
FDA Drug Application 021324 by PERRIGO PHARMA INTL
Application Number
021324
Application Type
New Drug Application
Sponsor Applicant
PERRIGO PHARMA INTL
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New formulation
Therapeutic Potential
Priority
Orphan Code
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
10/2/2001
N
4685
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-324_Entocort_Approv.pdf
10/2/2001
AP
0
10/2/2001
N
4686
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21324lbl.pdf
10/2/2001
AP
0
10/2/2001
N
4687
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-324_Entocort.cfm
10/2/2001
AP
0
10/2/2001
N
5590
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21324PPIlbl.pdf
5/7/2003
AP
0
8/9/2002
SCS
8964
001
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21324scs001ltr.pdf
6/3/2004
AP
0
8/14/2002
SCE
AP
0
10/3/2002
SCS
8963
003
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21324scs003ltr.pdf
6/3/2004
AP
0
3/13/2003
SCM
4498
004
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21324scm004ltr.pdf
3/26/2003
AP
0
4/29/2005
SE5
11569
005
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021324s005ltr.pdf
5/3/2005
AP
0
4/29/2005
SE5
11573
005
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021324s005lbl.pdf
5/3/2005
AP
0
6/22/2009
SLR
22815
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021324s008ltr.pdf
6/24/2009
AP
0
6/22/2009
SLR
22818
008
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021324s008lbl.pdf
6/24/2009
AP
0
12/20/2011
SLR
31213
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021324s009ltr.pdf
12/22/2011
AP
0
12/20/2011
SLR
31230
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021324s009lbl.pdf
12/23/2011
AP
0
4/29/2016
SE8
45843
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021324s012s013lbl.pdf
5/3/2016
AP
0
4/29/2016
SE8
45848
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021324Orig1s012,s013ltr.pdf
5/3/2016
AP
0
4/29/2016
SE8
45844
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021324s012s013lbl.pdf
5/3/2016
AP
0
4/29/2016
SE8
45849
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021324Orig1s012,s013ltr.pdf
5/3/2016
AP
0
10/5/2016
SCM
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