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
CLEOCIN PHOSPHATE از شرکت PFIZER
Abbreviated New Drug Application (ANDA): 062803
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLEOCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription |
AP |
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 |
|---|---|---|---|---|---|---|---|
| 10/16/1987 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/11/2017 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2016 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 08/18/2016 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 08/18/2016 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 08/18/2016 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 08/18/2016 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 04/05/2000 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/02/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 01/12/1998 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/06/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/22/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
CLEOCIN PHOSPHATE
INJECTABLE;INJECTION; EQ 150MG BASE/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLEOCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 050441 | PFIZER |
| CLEOCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062803 | PFIZER |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062800 | ALMAJECT |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062943 | ALMAJECT |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065346 | FRESENIUS KABI USA |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065347 | FRESENIUS KABI USA |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090108 | SAGENT PHARMS INC |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090109 | SAGENT PHARMS INC |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 062889 | WEST-WARD PHARMS INT |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 150MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065206 | WEST-WARD PHARMS INT |
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