Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 014860
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE EQ 300MG BASE;EQ 45MG 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
12/09/1968 ORIG-1 Approval Type 4 - New Combination PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/29/1990 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/03/1987 SUPPL-14 Labeling

Label is not available on this site.

01/26/1984 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/04/1986 SUPPL-12 Labeling

Label is not available on this site.

05/15/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1981 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/09/1976 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

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