Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200174
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
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% | OINTMENT;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 |
---|---|---|---|---|---|---|---|
12/12/2014 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200174Orig1s000ltr.pdf |
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
OINTMENT;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% | OINTMENT;TOPICAL | Prescription | No | AB | 200174 | PADAGIS ISRAEL |
TACLONEX | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | 0.064%;0.005% | OINTMENT;TOPICAL | Prescription | Yes | AB | 021852 | LEO PHARMA AS |