Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088571
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.005MG/ML;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
09/13/1985 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
07/15/2020 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

07/15/2020 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

04/09/2010 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

01/02/2002 SUPPL-7 Labeling

Label is not available on this site.

12/27/2002 SUPPL-6 Labeling

Label is not available on this site.

02/15/1991 SUPPL-5 Labeling

Label is not available on this site.

05/10/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/07/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

INJECTABLE;INJECTION; 0.005MG/ML;1.5%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.005MG/ML;1.5% INJECTABLE;INJECTION Prescription No AP 088571 HOSPIRA
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.005MG/ML;1.5% INJECTABLE;INJECTION Prescription No AP 089645 HOSPIRA
XYLOCAINE W/ EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.005MG/ML;1.5% INJECTABLE;INJECTION Prescription Yes AP 006488 FRESENIUS KABI USA

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