Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076290
Company: HI TECH PHARMA
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
09/25/2003 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/22/2010 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

06/22/2010 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

07/01/2009 SUPPL-1 Labeling

Label is not available on this site.

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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