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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019941
Company: TEVA BRANDED PHARM

Products on NDA 019941

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMLA	LIDOCAINE; PRILOCAINE	2.5%;2.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019941

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/1992	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
11/02/2018	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019941s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019941Orig1s021Ltr.pdf
01/25/2013	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/27/2006	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019941s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019941s018LTR.pdf
12/19/2005	SUPPL-17	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019941s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019941s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019941_S017_EMLA_CREAM.pdf
01/27/2003	SUPPL-15	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19941scp014,015ltr.pdf
06/02/2000	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
04/20/2000	SUPPL-12	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019941_S012_EMLA_CREAM.pdf
01/28/2000	SUPPL-11	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19941S11LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19941S11LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-941S011.pdf
03/11/1999	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19941s10ltr.pdf
02/04/1998	SUPPL-9	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019941s008_emla.pdf
02/04/1998	SUPPL-8	Efficacy-Accelerated Approval Confirmatory Study	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019941s008_emla.pdf
02/04/1998	SUPPL-7	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019941s008_emla.pdf
05/31/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/31/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/27/1995	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/11/1994	SUPPL-2	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019941_S002_EMLA_CREAM.pdf

Labels for NDA 019941

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2018	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019941s021lbl.pdf
04/27/2006	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019941s018lbl.pdf
12/19/2005	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019941s017lbl.pdf
01/28/2000	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19941S11LBL.PDF

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