Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202590
Company: EMCURE PHARMS 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 Discontinued None No No
LEVOFLOXACIN LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE;INJECTION Discontinued None 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
01/24/2013 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
05/03/2019 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/18/2018 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/17/2019 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/14/2016 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/14/2016 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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