Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205772
Company: GLENMARK PHARMS
Company: GLENMARK PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CALCIPOTRIENE | CALCIPOTRIENE | 0.005% | CREAM;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 |
---|---|---|---|---|---|---|---|
06/09/2015 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205772Orig1s000ltr.pdf |
CALCIPOTRIENE
CREAM;TOPICAL; 0.005%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CALCIPOTRIENE | CALCIPOTRIENE | 0.005% | CREAM;TOPICAL | Prescription | No | AB | 205772 | GLENMARK PHARMS |
DOVONEX | CALCIPOTRIENE | 0.005% | CREAM;TOPICAL | Prescription | Yes | AB | 020554 | LEO PHARMA AS |