Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205540
Company: GLAND PHARMA LTD
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
04/22/2020 ORIG-1 Approval STANDARD

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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