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FDA Drug Application 020375 by BAYER HLTHCARE

Application Number	020375
Application Type	New Drug Application
Sponsor Applicant	BAYER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New manufacturer
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	12/22/1994	N
AP	4/25/1995	SCS	6467	001	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020375-S1_Climara_toc.cfm	8/8/2003
AP	2/28/1995	SCM	6468	002	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020375-S2_Climara_toc.cfm	8/8/2003
AP	9/22/1995	SCM	6469	003	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020375-S3_Climara_toc.cfm	8/8/2003
AP	10/10/1995	SCS	6470	004	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020375-S4_Climara_toc.cfm	8/8/2003
AP	5/17/1996	SCM	6471	005	http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020375-S5_Climara_toc.cfm	8/8/2003
AP	4/11/1997	SE3
AP	9/16/1997	SCS	6472	007	http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020375-S7_Climara_toc.cfm	8/8/2003
AP	2/27/1998	SCF	5638	008	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020375s8_climara.cfm	5/15/2003
AP	3/23/1998	SCS	590	009	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20375s009_Climara.cfm	3/23/1998
AP	3/23/1998	SCS	4628	009	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20375s009_Climara_appltr.pdf	3/23/1998
AP	3/23/1998	SCS	4629	009	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20375s009_Climara_prntlbl.pdf	3/23/1998
AP	6/11/1998	SCS	5648	010	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020375s10_climara.cfm	5/22/2003
AP	3/5/1999	SLR	2491	011	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020994.cfm	3/5/1999
AP	3/5/1999	SLR	4626	011	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020994_appltr_prntlbl.pdf	3/5/1999
AP	3/5/1999	SLR	4627	011	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020994_appltr_prntlbl.pdf	3/5/1999
AP	6/11/1998	SCE	5637	012	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020375s12_climara.cfm	5/15/2003
AP	5/20/1999	SLR	2492	013	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20375-s013_climara.pdf	5/20/1999
AP	4/4/2001	SLR	5020	014	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20375S14ltr.pdf	4/11/2001
AP	4/4/2001	SLR	5615	014	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20375S14lbl.pdf	4/11/2001
AP	4/5/2001	SE1	5021	016	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20375S16ltr.pdf	4/5/2001
AP	4/5/2001	SE1	5454	016	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20375s16lbl.pdf	4/24/2003
AP	4/5/2001	SE1	10243	016	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-375s016_Berlex.cfm	9/21/2004
AP	9/13/2002	SCM
AP	12/19/2002	SCM
AP	1/22/2004	SLR	7646	020	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20375slr020ltr.pdf	2/2/2004
AP	1/22/2004	SLR	7695	020	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020375S020lbl.pdf	2/12/2004
AP	3/18/2005	SLR	11279	021	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20375s021ltr.pdf	3/23/2005
AP	6/22/2005	SLR	11889	022	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020375s022ltr.pdf	6/24/2005
AP	6/22/2005	SLR	11890	022	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020375s022lbl.pdf	6/24/2005
AP	12/28/2005	SLR	13334	023	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020375s023LBL.pdf	1/5/2006
AP	12/28/2005	SLR	13351	023	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020375s023ltr.pdf	1/6/2006
AP	3/28/2007	SCS
AP	1/3/2008	SLR	18733	026	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020375s026lbl.pdf	1/8/2008
AP	1/3/2008	SLR	18793	026	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020375s026ltr.pdf	1/9/2008
AP	10/9/2013	SLR	37407	027	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020375Orig1s027ltr.pdf	10/11/2013
AP	10/9/2013	SLR	37445	027	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020375s027lbl.pdf	10/17/2013
AP	10/10/2013	SLR	37620	028	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020375Orig1s028ltr.pdf	10/31/2013
AP	5/14/2013	SCM
AP	8/6/2015	SCM

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