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 SUN PHARM INDS LTD
Abbreviated New Drug Application (ANDA): 065061
Company: SUN PHARM INDS LTD
| 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 |
|---|---|---|---|---|---|---|---|
| 02/02/2001 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65061ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/19/2019 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/19/2019 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/19/2019 | SUPPL-32 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/19/2019 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/19/2019 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/21/2014 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/29/2013 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/29/2013 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/10/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/26/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/10/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/15/2002 | SUPPL-1 | Manufacturing (CMC)-Packaging |
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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