Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018594
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOPICORT | DESOXIMETASONE | 0.05% | OINTMENT;TOPICAL | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
01/17/1985 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/06/2015 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/26/2014 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/26/2014 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/12/2014 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/07/2012 | SUPPL-8 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018594Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018594Orig1s008ltr.pdf | |
05/14/2010 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018594s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018594s007ltr.pdf | |
07/26/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/13/1993 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/08/1988 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/19/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/07/2012 | SUPPL-8 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018594Orig1s008lbl.pdf |
05/14/2010 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018594s007lbl.pdf |
TOPICORT
OINTMENT;TOPICAL; 0.05%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DESOXIMETASONE | DESOXIMETASONE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 208044 | LUPIN |
DESOXIMETASONE | DESOXIMETASONE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 209973 | THE J MOLNER |
TOPICORT | DESOXIMETASONE | 0.05% | OINTMENT;TOPICAL | Prescription | Yes | AB | 018594 | TARO |