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
BIOSCRUB از شرکت GRIFFEN
New Drug Application (NDA): 019822
Company: GRIFFEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BIOSCRUB | CHLORHEXIDINE GLUCONATE | 4% | SPONGE;TOPICAL | Over-the-counter |
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 |
|---|---|---|---|---|---|---|---|
| 03/31/1989 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
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 |
|---|---|---|---|---|---|
| 05/11/2018 | SUPPL-8 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019822Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019822Orig1s008ltr.pdf |
||
| 01/07/2013 | SUPPL-7 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019822Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019822Orig1s007ltr.pdf |
||
| 01/09/2003 | SUPPL-6 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19822slr006_Pre-Scrub_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19822slr006ltr.pdf |
||
| 02/13/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/11/1991 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/11/2018 | SUPPL-8 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019822Orig1s008lbl.pdf | |
| 01/07/2013 | SUPPL-7 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019822Orig1s007lbl.pdf | |
| 01/09/2003 | SUPPL-6 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19822slr006_Pre-Scrub_lbl.pdf |
BIOSCRUB
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SPONGE;TOPICAL; 4%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| BIOSCRUB | CHLORHEXIDINE GLUCONATE | 4% | SPONGE;TOPICAL | Over-the-counter | No | 019822 | GRIFFEN |
| CHLORHEXIDINE GLUCONATE | CHLORHEXIDINE GLUCONATE | 4% | SPONGE;TOPICAL | Over-the-counter | No | 072525 | BECTON DICKINSON |
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