Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088325
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 0.5% 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
07/31/1984 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-23 Labeling-Package Insert

Label is not available on this site.

02/23/2005 SUPPL-14 Labeling

Label is not available on this site.

05/05/1998 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

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

Label is not available on this site.

01/16/1997 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/10/1990 SUPPL-6 Labeling

Label is not available on this site.

12/19/1988 SUPPL-5 Labeling

Label is not available on this site.

10/14/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/01/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/01/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/17/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 0.5%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE;INJECTION Prescription No AP 088328 HOSPIRA
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE;INJECTION Prescription No AP 088325 HOSPIRA
XYLOCAINE LIDOCAINE HYDROCHLORIDE 0.5% INJECTABLE;INJECTION Prescription Yes AP 006488 FRESENIUS KABI USA

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