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
BACTRIM از شرکت SUN PHARM INDS INC
New Drug Application (NDA): 018374
Company: SUN PHARM INDS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BACTRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 80MG/ML;16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 06/23/1981 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
PRIORITY |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/21/2021 | SUPPL-28 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018374s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018374Orig1s028ltr.pdf |
||
| 07/29/2020 | SUPPL-27 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018374s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018374Orig1s027ltr.pdf |
||
| 02/09/2018 | SUPPL-26 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018374s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018374Orig1s026ltr.pdf |
||
| 03/04/2017 | SUPPL-25 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018374s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018374Orig1s025ltr.pdf |
||
| 09/13/2001 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/21/1997 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/19/1997 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/05/1991 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/23/1992 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1987 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/11/1987 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/05/1985 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1985 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/1987 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/23/1984 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/02/1984 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/30/1983 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/30/1983 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/24/1982 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/13/1982 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/1981 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/1981 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/21/2021 | SUPPL-28 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018374s028lbl.pdf | |
| 07/29/2020 | SUPPL-27 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018374s027lbl.pdf | |
| 02/09/2018 | SUPPL-26 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018374s026lbl.pdf | |
| 03/04/2017 | SUPPL-25 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018374s025lbl.pdf |
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