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
CALCIPOTRIENE از شرکت TOLMAR
Abbreviated New Drug Application (ANDA): 077029
Company: TOLMAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CALCIPOTRIENE | CALCIPOTRIENE | 0.005% | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 11/20/2009 | 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 |
|---|---|---|---|---|---|
| 11/30/2012 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
CALCIPOTRIENE
SOLUTION;TOPICAL; 0.005%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CALCIPOTRIENE | CALCIPOTRIENE | 0.005% | SOLUTION;TOPICAL | Prescription | No | AT | 077579 | AKORN |
| CALCIPOTRIENE | CALCIPOTRIENE | 0.005% | SOLUTION;TOPICAL | Prescription | No | AT | 078468 | COSETTE |
| CALCIPOTRIENE | CALCIPOTRIENE | 0.005% | SOLUTION;TOPICAL | Prescription | No | AT | 078305 | FOUGERA PHARMS |
| CALCIPOTRIENE | CALCIPOTRIENE | 0.005% | SOLUTION;TOPICAL | Prescription | No | AT | 207163 | NOVEL LABS INC |
| CALCIPOTRIENE | CALCIPOTRIENE | 0.005% | SOLUTION;TOPICAL | Prescription | No | AT | 077029 | TOLMAR |
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