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 از شرکت ALMAJECT
Abbreviated New Drug Application (ANDA): 062800
Company: ALMAJECT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLINDAMYCIN 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 |
|---|---|---|---|---|---|---|---|
| 07/24/1987 | 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 |
|---|---|---|---|---|---|
| 01/18/2013 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/10/2008 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 08/12/2005 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/12/2004 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 01/23/2001 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/26/2000 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/03/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/20/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/24/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/22/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
CLINDAMYCIN 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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