Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019941
Company: TEVA BRANDED PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EMLA LIDOCAINE; PRILOCAINE 2.5%;2.5% 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
12/30/1992 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
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

EMLA

CREAM;TOPICAL; 2.5%;2.5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EMLA LIDOCAINE; PRILOCAINE 2.5%;2.5% CREAM;TOPICAL Prescription Yes AB 019941 TEVA BRANDED PHARM
LIDOCAINE AND PRILOCAINE LIDOCAINE; PRILOCAINE 2.5%;2.5% CREAM;TOPICAL Prescription No AB 076453 FOUGERA PHARMS
LIDOCAINE AND PRILOCAINE LIDOCAINE; PRILOCAINE 2.5%;2.5% CREAM;TOPICAL Prescription No AB 076290 HI TECH PHARMA
LIDOCAINE AND PRILOCAINE LIDOCAINE; PRILOCAINE 2.5%;2.5% CREAM;TOPICAL Prescription No AB 205887 TELIGENT PHARMA INC
LIDOCAINE AND PRILOCAINE LIDOCAINE; PRILOCAINE 2.5%;2.5% CREAM;TOPICAL Prescription No AB 076320 TOLMAR

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