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 PADAGIS US
Abbreviated New Drug Application (ANDA): 065049
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB;TOPICAL | Prescription |
AT |
No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/25/2000 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65049ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/03/2020 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/03/2020 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/15/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/14/2014 | SUPPL-11 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/19/2010 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/27/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/27/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/21/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/21/2001 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/21/2001 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
CLINDAMYCIN PHOSPHATE
SWAB;TOPICAL; EQ 1% BASE
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB;TOPICAL | Prescription | No | AT | 065513 | AKORN |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB;TOPICAL | Prescription | No | AT | 065049 | PADAGIS US |
| CLINDETS | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB;TOPICAL | Prescription | No | AT | 064136 | PADAGIS US |
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