Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083158
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription AP No Yes
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 2% INJECTABLE;INJECTION Prescription AP No Yes
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 20% INJECTABLE;INJECTION Discontinued None No No
LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% LIDOCAINE HYDROCHLORIDE 200MG/100ML INJECTABLE;INJECTION Discontinued None No No
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% LIDOCAINE HYDROCHLORIDE 400MG/100ML INJECTABLE;INJECTION Discontinued None 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
10/31/1972 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/03/2002 SUPPL-96 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/25/2002 SUPPL-95 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

01/02/2002 SUPPL-94 Labeling

Label is not available on this site.

10/03/1996 SUPPL-92 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/02/1995 SUPPL-90 Manufacturing (CMC)

Label is not available on this site.

11/16/1995 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

09/20/1996 SUPPL-88 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/20/1994 SUPPL-87 Labeling

Label is not available on this site.

06/20/1994 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

07/23/1991 SUPPL-85 Labeling

Label is not available on this site.

09/20/1990 SUPPL-84 Labeling

Label is not available on this site.

08/04/1989 SUPPL-83 Labeling

Label is not available on this site.

09/20/1990 SUPPL-81 Labeling

Label is not available on this site.

04/18/1990 SUPPL-80 Labeling

Label is not available on this site.

08/05/1986 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

02/18/1986 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

08/13/1985 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

10/26/1984 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

05/16/1983 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

09/23/1982 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

07/19/1982 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

06/23/1982 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

06/23/1982 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

06/23/1982 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

06/23/1982 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

LIDOCAINE HYDROCHLORIDE

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

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

LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%

There are no Therapeutic Equivalents.

LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%

There are no Therapeutic Equivalents.

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