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
Abbreviated New Drug Application (ANDA): 064160
Company: FOUGERA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 01/28/2000 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/64160ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/02/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/16/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/31/2003 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/16/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/27/2001 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CLINDAMYCIN PHOSPHATE
GEL;TOPICAL; EQ 1% BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLEOCIN T | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | Yes | AB | 050615 | PFIZER |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB | 212438 | ENCUBE |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB | 064160 | FOUGERA PHARMS |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB | 214251 | GLENMARK PHARMS LTD |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB | 212104 | PADAGIS ISRAEL |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB | 211872 | SOLARIS PHARMA CORP |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | GEL;TOPICAL | Prescription | No | AB | 214052 | TARO PHARMS |
منبع : www.accessdata.fda.gov
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