Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018461
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 100MG/100ML INJECTABLE;INJECTION Discontinued None No No
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
04/22/1981 ORIG-1 Approval Type 3 - New Dosage Form 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
02/07/2017 SUPPL-58 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018461s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018461Orig1s058ltr.pdf
04/07/2015 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

03/05/2012 SUPPL-56 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018461s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018461s056ltr.pdf
02/27/2012 SUPPL-55 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018461s055ltr.pdf
12/11/2003 SUPPL-52 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18461slr052ltr.pdf
01/23/2002 SUPPL-50 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-461S050_Lidocaine.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18461s50ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-461S050_Lidocaine.pdf
11/23/1999 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/03/1999 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

09/18/1998 SUPPL-46 Labeling

Label is not available on this site.

09/29/1994 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1994 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1993 SUPPL-43 Labeling

Label is not available on this site.

04/03/1991 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1991 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/1990 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1991 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1991 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1989 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1989 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1987 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/28/1987 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

06/19/1986 SUPPL-31 Labeling

Label is not available on this site.

02/27/1986 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/15/1985 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1985 SUPPL-26 Labeling

Label is not available on this site.

06/13/1985 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1984 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/1986 SUPPL-23 Labeling

Label is not available on this site.

02/28/1984 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1984 SUPPL-21 Labeling

Label is not available on this site.

06/11/1985 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/1983 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1985 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1984 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/1982 SUPPL-12 Labeling

Label is not available on this site.

11/20/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1982 SUPPL-9 Labeling

Label is not available on this site.

02/22/1982 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1982 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1981 SUPPL-6 Labeling

Label is not available on this site.

10/01/1981 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1982 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1981 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/1981 SUPPL-2 Labeling

Label is not available on this site.

07/22/1981 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/07/2017 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018461s058lbl.pdf
03/05/2012 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018461s056lbl.pdf
01/23/2002 SUPPL-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-461S050_Lidocaine.pdf

LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

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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