Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088586
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 1% 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
07/24/1985 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
05/18/2010 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

05/21/2007 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

12/29/2000 SUPPL-16 Labeling

Label is not available on this site.

07/28/1992 SUPPL-14 Labeling

Label is not available on this site.

03/08/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/01/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/15/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/15/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/15/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/15/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/15/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/22/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/22/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/22/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/12/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

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

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