Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010585
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LERITINE ANILERIDINE HYDROCHLORIDE EQ 25MG BASE 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
08/15/1957 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/18/1978 SUPPL-10 Labeling

Label is not available on this site.

11/24/1975 SUPPL-8 Labeling

Label is not available on this site.

03/31/1975 SUPPL-7 Labeling

Label is not available on this site.

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