Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074904
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOPICORT | DESOXIMETASONE | 0.05% | GEL;TOPICAL | Prescription | AB | No | 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 |
---|---|---|---|---|---|---|---|
07/14/1998 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74904ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74904ap.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/05/2012 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/074904Orig1s015Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/074904Orig1s015ltr.pdf | |
11/23/2004 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
12/19/2003 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
07/24/2003 | SUPPL-5 | Labeling |
Label is not available on this site. |
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11/04/1999 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/09/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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04/07/1999 | 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 |
---|---|---|---|---|---|
01/05/2012 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/074904Orig1s015Lbl.pdf |
TOPICORT
GEL;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% | GEL;TOPICAL | Prescription | No | AB | 090727 | EPIC PHARMA LLC |
DESOXIMETASONE | DESOXIMETASONE | 0.05% | GEL;TOPICAL | Prescription | No | AB | 077552 | PADAGIS US |
DESOXIMETASONE | DESOXIMETASONE | 0.05% | GEL;TOPICAL | Prescription | No | AB | 204675 | RISING |
TOPICORT | DESOXIMETASONE | 0.05% | GEL;TOPICAL | Prescription | No | AB | 074904 | TARO |