Testicular Cancer

• FDA approval · 2024-05-10
  FDA Approved: CISPLATIN — Original Application (Apotex Corp.)

  FDA approved the original application for cisplatin from Apotex Corp., enabling the generic version to be marketed in the United States.

• FDA approval · 2017-03-17
  FDA Approved: CISPLATIN — Original Application (Sagent Pharmaceuticals)

  FDA approved Sagent Pharmaceuticals' original application for cisplatin, a generic injectable chemotherapy agent (ANDA approval).

• FDA approval · 2017-01-19
  FDA Approved: CISPLATIN — Supplemental Application (WG Critical Care, LLC)

  The FDA approved a supplemental application for cisplatin submitted by WG Critical Care, LLC.

• FDA approval · 2015-08-20
  FDA Approved: BLEOMYCIN — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Bleomycin submitted by Hospira, Inc., updating the product's indications or labeling.

• FDA approval · 2012-11-13
  FDA Approved: CISPLATIN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for cisplatin filed by Fresenius Kabi USA, LLC. This action confirms the continued approval of cispl…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2012-03-15
  FDA Approved: CISPLATIN — Supplemental Application (Teva Parenteral Medicines, Inc.)

  FDA approved a supplemental application for cisplatin from Teva Parenteral Medicines, Inc., marking an approved change to the drug's regulat…

• FDA approval · 2011-08-26
  FDA Approved: CISPLATIN — Supplemental Application (WG Critical Care, LLC)

  FDA approved a supplemental application for cisplatin submitted by WG Critical Care, LLC, resulting in an updated regulatory status for the …

• FDA approval · 2008-01-28
  FDA Approved: BLEOMYCIN — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved Fresenius Kabi USA's original ANDA for bleomycin sulfate, making a generic version of bleomycin available. Bleomycin is an …