Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203030
Company: UNICHEM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Discontinued None No No
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Discontinued None No No
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;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
10/14/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203030Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/07/2019 SUPPL-4 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

05/10/2016 SUPPL-1 Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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