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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021302
Company: BAUSCH

Medication Guide

Products on NDA 021302

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELIDEL	PIMECROLIMUS	1%	CREAM;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021302

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.

Labels for NDA 021302

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

Therapeutic Equivalents for NDA 021302

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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