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
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CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE از شرکت BAXTER HLTHCARE CORP
New Drug Application (NDA): 208083
Company: BAXTER HLTHCARE CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE | CLINDAMYCIN PHOSPHATE | EQ 300MG BASE/50ML (EQ 6MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription |
None |
Yes | Yes |
| CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE | CLINDAMYCIN PHOSPHATE | EQ 600MG BASE/50ML (EQ 12MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription |
None |
Yes | Yes |
| CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE | CLINDAMYCIN PHOSPHATE | EQ 900MG BASE/50ML (EQ 18MG BASE/ML) | SOLUTION;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 04/20/2017 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208083lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/18/2021 | SUPPL-4 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208083s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208083Orig1s004ltr.pdf |
||
| 08/01/2019 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208083s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208083Orig1s003ltr.pdf |
||
| 12/19/2017 | SUPPL-1 | Labeling-Container/Carton Labels |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/18/2021 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208083s004lbl.pdf | |
| 08/01/2019 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208083s003lbl.pdf | |
| 04/20/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208083lbl.pdf |
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