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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065488
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Discontinued None No No
AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;ORAL 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
05/15/2015 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
05/11/2018 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

08/24/2017 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/24/2017 SUPPL-2 Labeling-Package Insert Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/065488Orig1s002.pdf
05/25/2016 SUPPL-1 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/065488Orig1s001.pdf
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