Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203082
Company: AUROBINDO PHARMA LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription AP No No
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription AP 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
03/14/2013 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
10/29/2019 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

INJECTABLE;INJECTION; 1%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 207182 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 208474 B BRAUN MEDICAL INC
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 080404 FRESENIUS KABI USA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 083158 HOSPIRA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 088329 HOSPIRA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 212821 HUONS
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 083173 INTL MEDICATION
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 208017 SPECTRA MDCL DEVICES
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 080407 WEST-WARD PHARMS INT
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 088586 FRESENIUS KABI USA
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 088299 HOSPIRA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 203040 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 203082 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 080408 HOSPIRA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 084625 WEST-WARD PHARMS INT
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 040302 HOSPIRA
XYLOCAINE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription Yes AP 006488 FRESENIUS KABI USA

INJECTABLE;INJECTION; 2%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 207182 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 080404 FRESENIUS KABI USA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 040078 HOSPIRA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 083158 HOSPIRA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 088294 HOSPIRA
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 083173 INTL MEDICATION
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 080407 WEST-WARD PHARMS INT
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 088327 HOSPIRA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 203040 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 203082 AUROBINDO PHARMA LTD
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 017584 FRESENIUS KABI USA
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 084625 WEST-WARD PHARMS INT
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription No AP 040302 HOSPIRA
XYLOCAINE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription Yes AP 006488 FRESENIUS KABI USA

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