Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201615
Company: CHARTWELL RX
Company: CHARTWELL RX
| 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 | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 01/14/2013 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201615Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/30/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/14/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/14/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/14/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |