Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076453
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE AND PRILOCAINE LIDOCAINE; PRILOCAINE 2.5%;2.5% CREAM;TOPICAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/18/2003 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076453.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/21/2004 SUPPL-5 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf
07/21/2004 SUPPL-4 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf
07/21/2004 SUPPL-3 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf
01/21/2004 SUPPL-2 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf
06/14/2004 SUPPL-1 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf

LIDOCAINE AND PRILOCAINE

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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