Malaria

• FDA approval · 2022-10-25
  FDA Approved: PYRIMETHAMINE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for pyrimethamine from Aurobindo Pharma Limited.

• FDA approval · 2022-07-11
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for hydroxychloroquine sulfate from Aurobindo Pharma Limited.

• FDA approval · 2022-07-07
  FDA Approved: HYDROXYCHLOROQUINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for HYDROXYCHLOROQUINE from Chartwell RX, LLC under an ANDA, making a generic version available.

• FDA approval · 2022-05-03
  FDA Approved: PLAQUENIL — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approved a supplemental application for Plaquenil (hydroxychloroquine sulfate) submitted by Advanz Pharma (US) Corp. This action constit…

• FDA approval · 2022-05-03
  FDA Approved: CHLOROQUINE PHOSPHATE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for chloroquine phosphate from Amneal Pharmaceuticals of New York LLC. This action allows contin…

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• FDA approval · 2022-05-03
  FDA Approved: CHLOROQUINE PHOSPHATE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for chloroquine phosphate from Rising Pharma Holdings, Inc. This approval authorizes the continued c…

• FDA approval · 2022-05-03
  FDA Approved: CHLOROQUINE PHOSPHATE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for CHLOROQUINE PHOSPHATE from Rising Pharma Holdings, Inc.

• FDA approval · 2022-03-17
  FDA Approved: CHLOROQUINE PHOSPHATE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for chloroquine phosphate by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2022-02-25
  FDA Approved: ARAKODA — Supplemental Application (60 Degrees Pharmaceuticals, INC.)

  The FDA approved a supplemental application for ARAKODA (tafenoquine) by 60 Degrees Pharmaceuticals, expanding the medication’s labeling/ind…

• FDA approval · 2022-02-10
  FDA Approved: QUINIDINE SULFATE — Supplemental Application (EPIC PHARMA, LLC)

  FDA approved a supplemental application for Quinidine Sulfate tablets from Epic Pharma, LLC.

• FDA approval · 2022-01-14
  FDA Approved: SOVUNA — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved SOVUNA (hydroxychloroquine sulfate) under an original application by ANI Pharmaceuticals, Inc.

• FDA approval · 2021-10-25
  FDA Approved: ATOVAQUONE — Original Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved the original application for atovaquone, including the oral suspension, from PAI Holdings, LLC dba PAI Pharma, marking approval…

• FDA approval · 2021-09-14
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for hydroxychloroquine sulfate from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2021-08-23
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Ipca Laboratories Limited)

  The FDA approved a supplemental application for hydroxychloroquine sulfate from Ipca Laboratories Limited, approving changes to an already-a…

• FDA approval · 2021-08-13
  FDA Approved: PYRIMETHAMINE — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva's original application for pyrimethamine (generic) under an ANDA.

• FDA approval · 2020-04-30
  FDA Approved: CHLOROQUINE PHOSPHATE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for chloroquine phosphate from Amneal Pharmaceuticals of New York LLC under ANDA 080880.

• FDA approval · 2020-04-28
  FDA Approved: CHLOROQUINE PHOSPHATE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approves Amneal Pharmaceuticals of New York LLC's supplemental application for chloroquine phosphate, granting approval of the generic p…

• FDA approval · 2020-04-09
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for hydroxychloroquine sulfate from Aurobindo Pharma Limited.

• FDA approval · 2020-04-01
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for hydroxychloroquine sulfate from Aurobindo Pharma Limited.

• FDA approval · 2020-04-01
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Creekwood Pharmaceuticals LLC)

  The FDA approved Creekwood Pharmaceuticals LLC's supplemental application for hydroxychloroquine sulfate, authorizing the continued marketin…

• FDA approval · 2020-02-28
  FDA Approved: PYRIMETHAMINE — Original Application (DR.REDDYS LABORATORIES INC)

  FDA approved a pyrimethamine product from Dr. Reddy's Laboratories under an Original Application (ANDA207127), adding a generic option for t…

• FDA approval · 2019-12-13
  FDA Approved: QUININE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for QUININE SULFATE submitted by Teva Pharmaceuticals USA, Inc. This action updates the product …

• FDA approval · 2019-11-22
  FDA Approved: ATOVAQUONE AND PROGUANIL HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for atovaquone and proguanil hydrochloride from Mylan Pharmaceuticals Inc.

• FDA approval · 2019-11-07
  FDA Approved: ATOVAQUONE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)

  FDA approved a supplemental application for atovaquone submitted by Chartwell Governmental & Specialty RX, LLC.

• FDA approval · 2019-08-05
  FDA Approved: COARTEM — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for COARTEM (artemether and lumefantrine) submitted by Novartis Pharmaceuticals Corporation. Thi…