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
CONDYLOX از شرکت TEVA BRANDED PHARM
New Drug Application (NDA): 019795
Company: TEVA BRANDED PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CONDYLOX | PODOFILOX | 0.5% | SOLUTION;TOPICAL | Prescription |
AT |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 12/13/1990 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
PRIORITY |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/10/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/2015 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/23/2013 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/2014 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1994 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1991 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
CONDYLOX
SOLUTION;TOPICAL; 0.5%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CONDYLOX | PODOFILOX | 0.5% | SOLUTION;TOPICAL | Prescription | Yes | AT | 019795 | TEVA BRANDED PHARM |
| PODOFILOX | PODOFILOX | 0.5% | SOLUTION;TOPICAL | Prescription | No | AT | 075600 | PADAGIS US |
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