Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073193
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOPICORT | DESOXIMETASONE | 0.25% | CREAM;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 |
---|---|---|---|---|---|---|---|
11/29/1990 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/03/2012 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/073193SOrig1s33Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/073193Orig1s033ltr.pdf | |
02/29/2008 | SUPPL-27 | Labeling |
Label is not available on this site. |
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11/23/2004 | SUPPL-22 | Labeling |
Label is not available on this site. |
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02/19/2004 | SUPPL-21 | Labeling |
Label is not available on this site. |
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12/19/2003 | SUPPL-20 | Labeling |
Label is not available on this site. |
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06/20/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/03/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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04/09/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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09/17/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/15/1996 | SUPPL-5 | 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 |
---|---|---|---|---|---|
01/03/2012 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/073193SOrig1s33Lbl.pdf |
TOPICORT
CREAM;TOPICAL; 0.25%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DESOXIMETASONE | DESOXIMETASONE | 0.25% | CREAM;TOPICAL | Prescription | No | AB | 205082 | ACTAVIS MID ATLANTIC |
DESOXIMETASONE | DESOXIMETASONE | 0.25% | CREAM;TOPICAL | Prescription | No | AB | 078369 | FOUGERA PHARMS |
DESOXIMETASONE | DESOXIMETASONE | 0.25% | CREAM;TOPICAL | Prescription | No | AB | 208164 | LUPIN |
DESOXIMETASONE | DESOXIMETASONE | 0.25% | CREAM;TOPICAL | Prescription | No | AB | 076510 | PADAGIS ISRAEL |
DESOXIMETASONE | DESOXIMETASONE | 0.25% | CREAM;TOPICAL | Prescription | No | AB | 205594 | RISING |
DESOXIMETASONE | DESOXIMETASONE | 0.25% | CREAM;TOPICAL | Prescription | No | AB | 205620 | ZYDUS LIFESCIENCES |
TOPICORT | DESOXIMETASONE | 0.25% | CREAM;TOPICAL | Prescription | No | AB | 073193 | TARO |