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
BREATHTEK UBT FOR H-PYLORI از شرکت OTSUKA AMERICA
New Drug Application (NDA): 020586
Company: OTSUKA AMERICA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BREATHTEK UBT FOR H-PYLORI | UREA C-13 | EQ 75MG/POUCH | FOR SOLUTION;ORAL | Discontinued |
None |
No | No |
| MERETEK UBT KIT (W/ PRANACTIN) | UREA C-13 | 125MG/VIAL | FOR SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 09/17/1996 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
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 |
|---|---|---|---|---|---|
| 05/10/2001 | SUPPL-4 | Efficacy-New Dosing Regimen |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20586s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20586-S004%20AP%20ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-586s004_Pranactin.cfm |
||
| 05/13/1999 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/23/1997 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/10/2001 | SUPPL-4 |
Efficacy-New Dosing Regimen |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20586s4lbl.pdf |
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