Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019830
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 200MG/100ML INJECTABLE;INJECTION Prescription AP No No
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 400MG/100ML INJECTABLE;INJECTION Prescription AP No No
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 800MG/100ML 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
04/08/1992 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
01/13/2017 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/01/2013 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019830s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019830Orig1s018ltr.pdf
08/22/2014 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/24/2004 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19830slr008ltr.pdf
07/15/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/2002 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/13/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/31/1994 SUPPL-2 Labeling

Label is not available on this site.

03/16/1993 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/01/2013 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019830s018lbl.pdf

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 200MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 200MG/100ML INJECTABLE;INJECTION Prescription No AP 019830 B BRAUN
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 200MG/100ML INJECTABLE;INJECTION Prescription No AP 018461 BAXTER HLTHCARE

LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 400MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 400MG/100ML INJECTABLE;INJECTION Prescription No AP 019830 B BRAUN
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 400MG/100ML INJECTABLE;INJECTION Prescription No AP 018461 BAXTER HLTHCARE

LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 800MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 800MG/100ML INJECTABLE;INJECTION Prescription No AP 019830 B BRAUN
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 800MG/100ML INJECTABLE;INJECTION Prescription No AP 018461 BAXTER HLTHCARE

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