Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075564
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Discontinued None No No
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE CAPSULE;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
10/27/2000 ORIG-1 Approval Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75564ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/18/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

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