Drugs@FDA: FDA-Approved Drugs
Company: LEGACY PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLODERM | CLOCORTOLONE PIVALATE | 0.1% | CREAM;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 |
|---|---|---|---|---|---|---|---|
| 08/22/1977 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 05/21/2009 | SUPPL-26 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 02/29/2008 | SUPPL-25 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/10/2003 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17765scp024_cloderm_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17765scp024ltr.pdf | |
| 03/14/2002 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/11/2001 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/27/2000 | SUPPL-21 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/15/1999 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1989 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/17/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1986 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/31/1984 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/01/1983 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1983 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/02/1981 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/31/1980 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/14/1980 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1980 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1980 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/08/1980 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/1980 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/09/1980 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/28/1979 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/19/1977 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/10/2003 | SUPPL-24 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17765scp024_cloderm_lbl.pdf |
CLODERM
CREAM;TOPICAL; 0.1%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOCORTOLONE PIVALATE | CLOCORTOLONE PIVALATE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 206370 | TARO |
| CLODERM | CLOCORTOLONE PIVALATE | 0.1% | CREAM;TOPICAL | Prescription | Yes | AB | 017765 | LEGACY PHARMA |