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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019830
Company: B BRAUN

Products on NDA 019830

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019830

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
05/19/2020	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019830s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019830Orig1s027ltr.pdf
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.

Labels for NDA 019830

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/19/2020	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019830s027lbl.pdf
02/01/2013	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019830s018lbl.pdf

Therapeutic Equivalents for NDA 019830

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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