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 FOUGERA PHARMS INC
Abbreviated New Drug Application (ANDA): 064159
Company: FOUGERA PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;TOPICAL | Prescription |
AT |
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 |
|---|---|---|---|---|---|---|---|
| 06/05/1997 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/064159.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/02/2005 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/16/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/26/2001 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CLINDAMYCIN PHOSPHATE
SOLUTION;TOPICAL; EQ 1% BASE
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLINDA-DERM | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;TOPICAL | Prescription | No | AT | 063329 | PADAGIS US |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;TOPICAL | Prescription | No | AT | 208767 | CADILA |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;TOPICAL | Prescription | No | AT | 209914 | ENCUBE ETHICALS |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;TOPICAL | Prescription | No | AT | 064159 | FOUGERA PHARMS INC |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;TOPICAL | Prescription | No | AT | 209846 | GLASSHOUSE PHARMS |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;TOPICAL | Prescription | No | AT | 064050 | PADAGIS US |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;TOPICAL | Prescription | No | AT | 065184 | TARO PHARM INDS |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION;TOPICAL | Prescription | No | AT | 206945 | TELIGENT |
منبع : www.accessdata.fda.gov
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