Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017584
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription AP No No
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 4% 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
03/26/1976 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
09/13/1996 SUPPL-28 Labeling

Label is not available on this site.

05/17/1993 SUPPL-27 Labeling

Label is not available on this site.

12/19/1995 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

12/19/1995 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/1991 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/07/1987 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

08/05/1994 SUPPL-19 Labeling

Label is not available on this site.

02/24/1986 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/1984 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1986 SUPPL-16 Labeling

Label is not available on this site.

02/14/1986 SUPPL-15 Labeling

Label is not available on this site.

04/30/1985 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1982 SUPPL-13 Labeling

Label is not available on this site.

12/08/1982 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1980 SUPPL-10 Labeling

Label is not available on this site.

07/10/1979 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/01/1977 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1977 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/12/1977 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/26/1978 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1978 SUPPL-4 Labeling

Label is not available on this site.

10/29/1976 SUPPL-3 Labeling

Label is not available on this site.

08/18/1976 SUPPL-2 Labeling

Label is not available on this site.

06/08/1976 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

LIDOCAINE HYDROCHLORIDE 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

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