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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078730
Company: ANI PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LANSOPRAZOLE LANSOPRAZOLE 15MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL Discontinued None No No
LANSOPRAZOLE LANSOPRAZOLE 30MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;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
10/15/2010 ORIG-1 Approval Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/078730Orig1s000.pdf
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