اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BANAN از شرکت SANKYO
New Drug Application (NDA): 050687
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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