Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016801
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XYLOCAINE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription AP Yes Yes
XYLOCAINE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 4% INJECTABLE;INJECTION Prescription AP Yes Yes
XYLOCAINE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 10% INJECTABLE;INJECTION Discontinued None No No
XYLOCAINE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 20% INJECTABLE;INJECTION Prescription AP Yes Yes
XYLOCAINE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription AP Yes 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
10/06/1969 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
04/18/2013 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

03/28/2013 SUPPL-41 Labeling-Container/Carton Labels

Label is not available on this site.

12/08/2000 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/1997 SUPPL-34 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/04/1997 SUPPL-33 Labeling

Label is not available on this site.

05/31/1995 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/1994 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1993 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/11/1989 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1988 SUPPL-28 Labeling

Label is not available on this site.

01/19/1988 SUPPL-27 Labeling

Label is not available on this site.

09/16/1987 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/04/1986 SUPPL-25 Labeling

Label is not available on this site.

09/04/1986 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1986 SUPPL-23 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/02/1983 SUPPL-22 Labeling

Label is not available on this site.

07/08/1982 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/25/1982 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1982 SUPPL-19 Labeling

Label is not available on this site.

04/27/1983 SUPPL-18 Labeling

Label is not available on this site.

07/22/1982 SUPPL-17 Labeling

Label is not available on this site.

07/22/1982 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

12/15/1980 SUPPL-15 Labeling

Label is not available on this site.

12/07/1979 SUPPL-14 Labeling

Label is not available on this site.

12/07/1979 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/1979 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/1978 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/29/1978 SUPPL-9 Labeling

Label is not available on this site.

09/29/1978 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/27/1976 SUPPL-7 Labeling

Label is not available on this site.

04/15/1976 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/1975 SUPPL-4 Labeling

Label is not available on this site.

XYLOCAINE PRESERVATIVE FREE

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 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 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
XYLOCAINE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription Yes AP 016801 FRESENIUS KABI USA

INJECTABLE;INJECTION; 4%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 4% INJECTABLE;INJECTION Prescription No AP 017584 FRESENIUS KABI USA
XYLOCAINE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 4% INJECTABLE;INJECTION Prescription Yes AP 016801 FRESENIUS KABI USA

INJECTABLE;INJECTION; 20%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 20% INJECTABLE;INJECTION Prescription No AP 083158 HOSPIRA
XYLOCAINE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 20% INJECTABLE;INJECTION Prescription Yes AP 016801 FRESENIUS KABI USA

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 083173 INTL MEDICATION
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription No AP 208017 SPECTRA MDCL DEVICES
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 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
XYLOCAINE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription Yes AP 016801 FRESENIUS KABI USA

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