Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050687
Company: SANKYO
Company: SANKYO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BANAN | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET;ORAL | Discontinued | None | No | No |
BANAN | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET;ORAL | Discontinued | None | No | No |
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-12 | 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-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 | 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-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 | 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-7 | 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 | |
05/25/1999 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
05/27/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
02/10/2000 | SUPPL-4 | 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 | |
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. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/10/2000 | SUPPL-12 | Labeling | 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 | Efficacy-New Dosing Regimen | 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 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf | |
02/10/2000 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf | |
02/10/2000 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf |