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Back to FDA Applications sponsored by US PHARM HOLDINGS
FDA Drug Application 017681 by US PHARM HOLDINGS
Application Number
017681
Application Type
New Drug Application
Sponsor Applicant
US PHARM HOLDINGS
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New manufacturer
Therapeutic Potential
Standard
Orphan Code
Action Type
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
9/9/1976
N
AP
0
2/24/1978
SCS
AP
0
2/27/1978
SCM
AP
0
11/25/1980
SLR
AP
0
11/25/1980
SLR
AP
0
3/19/1981
SDS
AP
0
5/26/1982
SCS
AP
0
4/25/1984
SCP
AP
0
5/3/1984
SCM
AP
0
1/3/1989
SCM
AP
0
4/28/1988
SCP
AP
0
8/9/1988
SCM
AP
0
6/10/2004
SLR
9367
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17681slr013ltr.pdf
6/15/2004
AP
0
6/10/2004
SLR
9381
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17681slr013_hiprex_lbl.pdf
6/15/2004
AP
0
11/21/2005
SLR
13141
014
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17681s014lbl.pdf
11/30/2005
AP
0
11/21/2005
SLR
13151
014
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17681s014ltr.pdf
11/30/2005
AP
0
8/1/2016
SCM
Back to FDA Applications sponsored by US PHARM HOLDINGS