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 HYDROCHLORIDE از شرکت COSETTE
Abbreviated New Drug Application (ANDA): 063029
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Prescription |
AB |
No | No |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 09/20/1989 | 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 |
|---|---|---|---|---|---|
| 04/10/2012 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/20/2010 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/14/2005 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 08/05/2005 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 08/05/2005 | SUPPL-16 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 09/30/2004 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/2000 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/21/2000 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/26/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/14/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/09/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CLINDAMYCIN HYDROCHLORIDE
CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLEOCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050162 | PFIZER |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065442 | AUROBINDO PHARMA |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063029 | COSETTE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065194 | EPIC PHARMA LLC |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065242 | LANNETT |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207402 | MICRO LABS |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065061 | SUN PHARM INDS LTD |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063083 | WATSON LABS |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065217 | ZYDUS PHARMS USA |
CAPSULE;ORAL; EQ 300MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLEOCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050162 | PFIZER |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065442 | AUROBINDO PHARMA |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063029 | COSETTE |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065194 | EPIC PHARMA LLC |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207402 | MICRO LABS |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065061 | SUN PHARM INDS LTD |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | No | AB | 063083 | WATSON LABS |
| CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065217 | ZYDUS PHARMS USA |
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