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 AND BETAMETHASONE DIPROPIONATE از شرکت TOLMAR
Abbreviated New Drug Application (ANDA): 210765
Company: TOLMAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | 0.064%;0.005% | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 05/11/2020 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210765Orig1s000ltr.pdf |
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
SUSPENSION;TOPICAL; 0.064%;0.005%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | 0.064%;0.005% | SUSPENSION;TOPICAL | Prescription | No | AB | 213269 | TARO PHARMS |
| CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | 0.064%;0.005% | SUSPENSION;TOPICAL | Prescription | No | AB | 210765 | TOLMAR |
| CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | 0.064%;0.005% | SUSPENSION;TOPICAL | Prescription | No | AB | 212367 | PADAGIS ISRAEL |
| TACLONEX | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | 0.064%;0.005% | SUSPENSION;TOPICAL | Prescription | Yes | AB | 022185 | LEO PHARMA AS |
نظرات کاربران