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
BACTOCILL IN PLASTIC CONTAINER از شرکت BAXTER HLTHCARE
New Drug Application (NDA): 050640
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BACTOCILL IN PLASTIC CONTAINER | OXACILLIN SODIUM | EQ 20MG BASE/ML | INJECTABLE;INJECTION | Prescription |
None |
Yes | Yes |
| BACTOCILL IN PLASTIC CONTAINER | OXACILLIN SODIUM | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription |
None |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/26/1989 | 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 |
|---|---|---|---|---|---|
| 02/24/2017 | SUPPL-20 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050640s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050640Orig1s020ltr.pdf |
||
| 01/06/2015 | SUPPL-17 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050640s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050640Orig1s017ltr.pdf |
||
| 11/21/2012 | SUPPL-15 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050640s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050640Orig1s015ltr.pdf |
||
| 04/19/2013 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/2011 | SUPPL-11 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050640s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050640s011ltr.pdf |
||
| 04/17/2008 | SUPPL-10 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050640s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050640s010ltr.pdf |
||
| 02/19/2014 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/2004 | SUPPL-7 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50640slr007ltr.pdf |
|
| 08/23/2002 | SUPPL-6 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50640slr006ltr.pdf |
|
| 02/02/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/05/1993 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/19/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/24/2017 | SUPPL-20 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050640s020lbl.pdf | |
| 01/06/2015 | SUPPL-17 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050640s017lbl.pdf | |
| 11/21/2012 | SUPPL-15 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050640s015lbl.pdf | |
| 10/13/2011 | SUPPL-11 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050640s011lbl.pdf | |
| 04/17/2008 | SUPPL-10 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050640s010lbl.pdf |
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