Action Type | Duplicate Counter | Action Date | Document Type | Application Document ID | Sequence Number | Document Title | Document URL | Document Date |
AP | 0 | 7/1/1997 | N | 111 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020667.cfm
| 7/1/1997 |
AP | 0 | 7/1/1997 | N | 4816 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020667a_appltr.pdf
| 7/1/1997 |
AP | 0 | 7/1/1997 | N | 33794 | 000 | |
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm320049.htm
| 9/19/2012 |
AP | 0 | 2/19/1998 | SLR | | | |
| |
AP | 0 | 2/12/1998 | SCM | | | |
| |
AP | 0 | 11/26/1997 | SCM | | | |
| |
AP | 0 | 12/13/1999 | SCS | | | |
| |
AP | 0 | 11/18/1999 | SCP | | | |
| |
AP | 0 | 9/3/1999 | SLR | | | |
| |
AP | 0 | 5/6/2003 | SLR | 5767 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20667slr008ltr.pdf
| 5/30/2003 |
AP | 0 | 5/6/2003 | SLR | 16760 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020667_S008_MirapexTOC.cfm
| 6/12/2007 |
AP | 0 | 12/4/2002 | SCE | | | |
| |
AP | 0 | 11/7/2006 | SE1 | 15331 | 011 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020667s011s013lbl.pdf
| 11/9/2006 |
AP | 0 | 11/7/2006 | SE1 | 15356 | 011 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020667s011, 020667s013LTR.pdf
| 11/14/2006 |
AP | 0 | 11/7/2006 | SE1 | 15332 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020667s011s013lbl.pdf
| 11/9/2006 |
AP | 0 | 11/7/2006 | SE1 | 15355 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020667s011, 020667s013LTR.pdf
| 11/14/2006 |
AP | 0 | 12/31/2008 | SLR | 21518 | 014 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020667s014,020667s017,020667s018ltr.pdf
| 1/6/2009 |
AP | 0 | 12/31/2008 | SLR | 21543 | 014 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf
| 1/6/2009 |
AP | 0 | 12/31/2008 | SLR | 21519 | 017 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020667s014,020667s017,020667s018ltr.pdf
| 1/6/2009 |
AP | 0 | 12/31/2008 | SLR | 21544 | 017 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf
| 1/6/2009 |
AP | 0 | 12/31/2008 | SLR | 21520 | 018 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020667s014,020667s017,020667s018ltr.pdf
| 1/6/2009 |
AP | 0 | 12/31/2008 | SLR | 21545 | 018 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf
| 1/6/2009 |
AP | 0 | 7/17/2012 | SLR | 33227 | 019 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf
| 7/18/2012 |
AP | 0 | 7/17/2012 | SLR | 33315 | 019 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf
| 7/30/2012 |
AP | 0 | 7/17/2012 | SLR | 33228 | 021 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf
| 7/18/2012 |
AP | 0 | 7/17/2012 | SLR | 33240 | 021 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf
| 7/19/2012 |
AP | 0 | 7/17/2012 | SLR | 33229 | 022 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf
| 7/18/2012 |
AP | 0 | 7/17/2012 | SLR | 33241 | 022 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf
| 7/19/2012 |
AP | 0 | 7/17/2012 | SLR | 33230 | 023 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf
| 7/18/2012 |
AP | 0 | 7/17/2012 | SLR | 33242 | 023 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf
| 7/19/2012 |
AP | 0 | 7/17/2012 | SLR | 33231 | 024 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf
| 7/18/2012 |
AP | 0 | 7/17/2012 | SLR | 33239 | 024 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf
| 7/19/2012 |
AP | 0 | 5/13/2011 | SE8 | 28811 | 025 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020667s025ltr.pdf
| 5/16/2011 |
AP | 0 | 5/13/2011 | SE8 | 28838 | 025 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020667s025lbl.pdf
| 5/16/2011 |
AP | 0 | 8/31/2012 | SE8 | 33644 | 027 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s027ltr.pdf
| 9/5/2012 |
AP | 0 | 8/31/2012 | SE8 | 33670 | 027 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s027lbl.pdf
| 9/6/2012 |
AP | 0 | 3/1/2013 | SLR | 35324 | 029 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020667Orig1s029ltr.pdf
| 3/4/2013 |
AP | 0 | 3/1/2013 | SLR | 35340 | 029 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020667s029lbl.pdf
| 3/5/2013 |
AP | 0 | 3/27/2015 | SLR | 42325 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020667Orig1s030ltr.pdf
| 3/31/2015 |
AP | 0 | 3/27/2015 | SLR | 42383 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbledt.pdf
| 4/2/2015 |
AP | 0 | 3/27/2015 | SLR | 42390 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbl.pdf
| 4/2/2015 |
AP | 0 | 3/27/2015 | SLR | 42415 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020667Orig1s030ltr.pdf
| 4/3/2015 |
AP | 1 | 4/1/2015 | SLR | 42325 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020667Orig1s030ltr.pdf
| 3/31/2015 |
AP | 1 | 4/1/2015 | SLR | 42383 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbledt.pdf
| 4/2/2015 |
AP | 1 | 4/1/2015 | SLR | 42390 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbl.pdf
| 4/2/2015 |
AP | 1 | 4/1/2015 | SLR | 42415 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020667Orig1s030ltr.pdf
| 4/3/2015 |
AP | 0 | 5/11/2015 | SCM | | | |
| |
AP | 0 | 11/20/2015 | SCM | | | |
| |
AP | 0 | 1/14/2016 | SLR | 44966 | 033 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020667Orig1s033ltr.pdf
| 1/15/2016 |
AP | 0 | 1/14/2016 | SLR | 45014 | 033 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s033lbl.pdf
| 1/25/2016 |
AP | 0 | 7/28/2016 | SLR | 46685 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020667Orig1s034ltr.pdf
| 8/1/2016 |
AP | 0 | 7/28/2016 | SLR | 46702 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s034lbl.pdf
| 8/2/2016 |