Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040014
Company: HI TECH PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% SOLUTION;ORAL Prescription AT No 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
07/10/1995 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
11/02/2018 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
11/01/2018 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
04/02/2015 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
03/24/2015 SUPPL-4 Labeling-Container/Carton Labels

Label is not available on this site.
08/25/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

LIDOCAINE HYDROCHLORIDE

SOLUTION;ORAL; 2%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% SOLUTION;ORAL Prescription No AT 040014 HI TECH PHARMA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% SOLUTION;ORAL Prescription No AT 087872 WOCKHARDT BIO AG
LIDOCAINE VISCOUS LIDOCAINE HYDROCHLORIDE 2% SOLUTION;ORAL Prescription No AT 088802 HIKMA

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