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 WATSON LABS
Abbreviated New Drug Application (ANDA): 063083
Company: WATSON LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 07/31/1991 | 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 |
|---|---|---|---|---|---|
| 11/12/2014 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/2013 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/09/2005 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 03/15/2004 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 03/18/2003 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 03/18/2003 | SUPPL-15 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 02/19/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/25/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/01/2001 | SUPPL-11 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 05/01/2001 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/06/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/29/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1998 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1993 | 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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