FDA Drug Application 019308 by BAXTER HLTHCARE

Application Number	019308
Application Type	New Drug Application
Sponsor Applicant	BAXTER 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	4/5/1985	N
AP	5/28/1987	SCS
AP	7/25/1987	SCP
AP	1/12/1989	SCS
AP	7/26/1989	SCS
AP	2/15/1991	SCS
AP	3/26/1991	SCS
AP	4/29/1991	SCS
AP	12/11/1991	SCS
AP	9/30/1994	SCS
AP	2/18/1994	SCS
AP	4/29/1997	SCP
AP	11/24/1999	SCM
AP	4/14/2003	SLR	5682	017	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18008slr059,18037slr059,19308slr017ltr.pdf	5/29/2003
AP	8/14/2001	SCM
AP	6/2/2004	SLR	9111	020	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18008slr063,18037slr063,19308slr020ltr.pdf	6/7/2004
AP	8/26/2005	SCP	12695	022	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf	8/31/2005
AP	8/26/2005	SCP	12696	022	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf	8/31/2005
AP	4/20/2007	SLR	16296	023	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018008s066,018037s066,019308s023lbl.pdf	4/25/2007
AP	4/20/2007	SLR	16423	023	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018008s066, 018037s066, 019308s023ltr.pdf	5/1/2007
AP	9/10/2013	SLR	37064	027	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018008s070,018037s070,019308s027lbl.pdf	9/11/2013
AP	9/10/2013	SLR	37078	027	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018008Orig1s070,018037Orig1s070,019308Orig1s027ltr.pdf	9/12/2013

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