An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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.cfm
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.cfm
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.cfm
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.cfm
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.cfm
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.cfm
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.cfm
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

Top