Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080408
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Prescription AP No No
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE LIDOCAINE HYDROCHLORIDE 1.5% 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
09/28/1972 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
04/16/2010 SUPPL-48 Labeling-Package Insert

Label is not available on this site.

01/02/2002 SUPPL-31 Labeling

Label is not available on this site.

02/24/1997 SUPPL-30 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/03/1996 SUPPL-29 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/13/1989 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-26 Labeling

Label is not available on this site.

11/28/1988 SUPPL-25 Labeling

Label is not available on this site.

07/25/1986 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/09/1985 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/14/1982 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/14/1982 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

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 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 080404 FRESENIUS KABI USA
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

INJECTABLE;INJECTION; 1.5%
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 1.5% INJECTABLE;INJECTION Prescription No AP 080408 HOSPIRA
XYLOCAINE LIDOCAINE HYDROCHLORIDE 1.5% INJECTABLE;INJECTION Prescription Yes AP 006488 FRESENIUS KABI USA

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