Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021302
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-Container/Carton Labels, Labeling-Package Insert

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

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