Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091644
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOFLOXACIN LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE;INJECTION Prescription AP No No
LEVOFLOXACIN LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) 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
06/20/2011 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
05/15/2020 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/15/2020 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/13/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

08/13/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

01/03/2012 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

LEVOFLOXACIN

INJECTABLE;INJECTION; EQ 500MG/20ML (EQ 25MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOFLOXACIN LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE;INJECTION Prescription No AP 091644 AKORN
LEVOFLOXACIN LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE;INJECTION Prescription No AP 202328 AUROBINDO PHARMA LTD
LEVOFLOXACIN LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE;INJECTION Prescription No AP 091436 BAXTER HLTHCARE CORP
LEVOFLOXACIN LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE;INJECTION Prescription No AP 205540 GLAND PHARMA LTD

INJECTABLE;INJECTION; EQ 750MG/30ML (EQ 25MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOFLOXACIN LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE;INJECTION Prescription No AP 091644 AKORN
LEVOFLOXACIN LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE;INJECTION Prescription No AP 202328 AUROBINDO PHARMA LTD
LEVOFLOXACIN LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE;INJECTION Prescription No AP 205540 GLAND PHARMA LTD

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