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Back to FDA Applications sponsored by MYLAN
FDA Drug Application 020677 by MYLAN
Application Number
020677
Application Type
New Drug Application
Sponsor Applicant
MYLAN
Most Recent Label Available Flag
Current Patent Flag
Action Type
Approval
Chemical Type
New molecular entity (NME)
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
12/19/1996
N
AP
0
10/19/1999
SLR
10914
001
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-677s001s002_Zagam.cfm
1/6/2005
AP
0
10/19/1999
SLR
10915
002
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-677s001s002_Zagam.cfm
1/6/2005
AP
0
12/10/1999
SCM
10913
003
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-677s003_Zagam.cfm
1/6/2005
AP
0
10/2/2002
SLR
2024
004
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20677slr004ltr.pdf
10/2/2002
AP
0
10/2/2002
SLR
2025
004
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20677s4lbl.pdf
10/2/2002
AP
0
5/11/2001
SCM
AP
0
4/4/2003
SLR
4932
006
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020677s006lbl.pdf
4/7/2003
AP
0
4/4/2003
SLR
5380
006
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20677slr006ltr.pdf
4/18/2003
Back to FDA Applications sponsored by MYLAN