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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087634
Company: LEDERLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SPIRONOLACTONE SPIRONOLACTONE 25MG TABLET;ORAL Discontinued None No No
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/25/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/04/1982 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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