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
CLINDETS از شرکت PADAGIS US
Abbreviated New Drug Application (ANDA): 064136
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLINDETS | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB;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 |
---|---|---|---|---|---|---|---|
09/30/1996 | 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 |
---|---|---|---|---|---|
12/09/2003 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
11/01/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
10/17/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
06/29/2001 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/22/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/29/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CLINDETS
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 |
منبع : www.accessdata.fda.gov
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