Malaria

• FDA approval · 2008-12-18
  FDA Approved: MALARONE — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Malarone (atovaquone and proguanil hydrochloride) submitted by GlaxoSmithKline LLC.

• FDA approval · 2008-09-18
  FDA Approved: MEFLOQUINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for mefloquine hydrochloride submitted by Chartwell RX, LLC.

• FDA approval · 2008-07-28
  FDA Approved: PRIMAQUINE PHOSPHATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Primaquine Phosphate from Sanofi-Aventis U.S. LLC, indicating an approved change related to the …

• FDA approval · 2008-05-07
  FDA Approved: MALARONE — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for MALARONE (atovaquone and proguanil hydrochloride) submitted by GlaxoSmithKline LLC.

• FDA approval · 2008-02-20
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for hydroxychloroquine sulfate submitted by Teva Pharmaceuticals USA, Inc. The action represents an …

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• FDA approval · 2007-09-21
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Original Application (Zydus Lifesciences Limited)

  FDA approves the original ANDA for hydroxychloroquine sulfate, a generic version manufactured by Zydus Lifesciences Limited.

• FDA approval · 2007-06-20
  FDA Approved: PLAQUENIL — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approves a supplemental application for Plaquenil (hydroxychloroquine sulfate) submitted by Advanz Pharma (US) Corp.

• FDA approval · 2007-06-14
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Original Application (Ipca Laboratories Limited)

  FDA approved Ipca Laboratories Limited's original application for hydroxychloroquine sulfate as a generic product.