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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050688
Company: SANKYO

Products on NDA 050688

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BANAN	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION;ORAL	Discontinued	None	No	No
BANAN	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050688

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/07/1992	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2000	SUPPL-13	Labeling	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.html
02/10/2000	SUPPL-12	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.html
02/10/2000	SUPPL-11	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.html
02/10/2000	SUPPL-10	Labeling	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.html
02/10/2000	SUPPL-9	Labeling	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.html
02/10/2000	SUPPL-8	Efficacy-New Indication	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.html
05/27/1999	SUPPL-7	Labeling		Label is not available on this site.
02/10/2000	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50688S6ETCLTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan.html
05/26/1999	SUPPL-5	Labeling		Label is not available on this site.
06/16/1995	SUPPL-4	Efficacy-New Indication		Label is not available on this site.
04/08/1993	SUPPL-3	Labeling		Label is not available on this site.
10/12/1993	SUPPL-2	Labeling		Label is not available on this site.
12/22/1997	SUPPL-1	Efficacy-New Indication		Label is not available on this site.

Labels for NDA 050688

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2000	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
02/10/2000	SUPPL-12	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
02/10/2000	SUPPL-11	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
02/10/2000	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
02/10/2000	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
02/10/2000	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
02/10/2000	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf

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