Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021302
Company: BAUSCH
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ELIDEL | PIMECROLIMUS | 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 |
---|---|---|---|---|---|---|---|
12/13/2001 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21302lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-302_ELIDEL_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-302_Elidel.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/09/2016 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/21/2014 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/26/2014 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/04/2014 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/28/2014 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021302s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021302Orig1s018ltr.pdf | |
07/20/2010 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021302s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021302s014ltr.pdf | |
09/14/2007 | SUPPL-13 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
08/10/2007 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021302s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021302s012ltr.pdf | |
01/19/2006 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021302s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021302s011ltr.pdf | |
11/24/2004 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21302s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21302s005ltr.pdf | |
10/15/2003 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21302scp004_elidel_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21302scp004ltr.pdf | |
11/15/2002 | 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 |
---|---|---|---|---|---|
03/28/2014 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021302s018lbl.pdf | |
07/20/2010 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021302s014lbl.pdf | |
08/10/2007 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021302s012lbl.pdf | |
01/19/2006 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021302s011lbl.pdf | |
11/24/2004 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21302s005lbl.pdf | |
10/15/2003 | SUPPL-4 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21302scp004_elidel_lbl.pdf | |
12/13/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21302lbl.pdf |
ELIDEL
CREAM;TOPICAL; 1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ELIDEL | PIMECROLIMUS | 1% | CREAM;TOPICAL | Prescription | Yes | AB | 021302 | BAUSCH |
PIMECROLIMUS | PIMECROLIMUS | 1% | CREAM;TOPICAL | Prescription | No | AB | 209345 | ACTAVIS LABS UT INC |
PIMECROLIMUS | PIMECROLIMUS | 1% | CREAM;TOPICAL | Prescription | No | AB | 211769 | GLENMARK PHARMS LTD |