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
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER از شرکت SANDOZ INC
Abbreviated New Drug Application (ANDA): 201692
Company: SANDOZ INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 6MG BASE/ML | INJECTABLE;INJECTION | Prescription |
AP |
No | Yes |
| CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 12MG BASE/ML | INJECTABLE;INJECTION | Prescription |
AP |
No | Yes |
| CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 18MG BASE/ML | INJECTABLE;INJECTION | Prescription |
AP |
No | 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 |
|---|---|---|---|---|---|---|---|
| 05/31/2012 | ORIG-1 | Approval |
Not Applicable |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/201692Orig1s000Approv.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/18/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2020 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/18/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
INJECTABLE;INJECTION; EQ 6MG BASE/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 6MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203048 | AKORN |
| CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 6MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208084 | BAXTER HLTHCARE CORP |
| CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 6MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201692 | SANDOZ INC |
INJECTABLE;INJECTION; EQ 12MG BASE/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 12MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203048 | AKORN |
| CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 12MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208084 | BAXTER HLTHCARE CORP |
| CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 12MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201692 | SANDOZ INC |
INJECTABLE;INJECTION; EQ 18MG BASE/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 18MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203048 | AKORN |
| CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 18MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208084 | BAXTER HLTHCARE CORP |
| CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 18MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201692 | SANDOZ INC |
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