Back to FDA Applications sponsored by UPSHER SMITH

FDA Drug Application 075135 by UPSHER SMITH

Application Number	075135
Application Type	Abbreviated New Drug Application
Sponsor Applicant	UPSHER SMITH
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type
Therapeutic Potential
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document Title	Document URL	Document Date
AP	4/30/1998	N	446	000		http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135.cfm	5/28/1999
AP	4/30/1998	N	4981	000		http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135ap_appltr_prntlbl_chemr.pdf	4/30/1998
AP	4/30/1998	N	4982	000		http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135ap_appltr_prntlbl_chemr.pdf	4/30/1998
AP	4/30/1998	N	12475	000		http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm	8/1/2005
AP	4/30/1998	N	24043	000		http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088668.pdf	11/20/2009
AP	12/2/1999	SC	4389	001		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75135s001ltr.pdf	4/30/1998
AP	12/2/1999	SC	4614	001		http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf	10/29/2002
AP	12/2/1999	SCB	4390	002		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75135s002ltr.pdf	12/2/1999
AP	12/2/1999	SCB	4615	002		http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf	10/29/2002
AP	9/24/1999	SL	3108	003		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75135s003ltr.pdf	9/24/1999
AP	9/24/1999	SL	4616	003		http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf	10/29/2002
AP	2/1/2000	SB	4388	004		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75135s004ltr.pdf	2/1/2000
AP	2/1/2000	SB	4617	004		http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf	10/29/2002
AP	4/12/2000	SCB	4639	005	10/29/02	http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf	10/29/2002
AP	4/12/2000	SCR	4640	006		http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf	10/29/2002
AP	4/12/2000	SL	4641	007		http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf	10/29/2002
AP	8/20/2002	SL
AP	12/19/2002	SCB

Back to FDA Applications sponsored by UPSHER SMITH