Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016455
Company: ALMIRALL
Company: ALMIRALL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORDRAN | FLURANDRENOLIDE | 0.004MG/SQ CM | TAPE;TOPICAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 07/29/1969 | 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 |
|---|---|---|---|---|---|
| 01/13/2017 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/2010 | SUPPL-24 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/19/2000 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1997 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/18/1987 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/03/1987 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/19/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/20/1985 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/06/1982 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 11/14/1980 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/19/1977 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |