Apnea of Prematurity

• FDA approval · 2025-09-26
  FDA Approved: CAFFEINE CITRATE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for caffeine citrate (generic) from Fresenius Kabi USA, LLC.

• FDA approval · 2025-09-16
  FDA Approved: CAFFEINE CITRATE — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for caffeine citrate submitted by Fresenius Kabi USA, LLC.

• FDA approval · 2025-05-23
  FDA Approved: CAFFEINE CITRATE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for caffeine citrate from Fresenius Kabi USA, LLC.

• FDA approval · 2025-04-24
  FDA Approved: CAFFEINE CITRATE — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for caffeine citrate by Eugia US LLC under the ANDA program.

• EMA approval · 2025-03-12
  EMA Authorised: Gencebok (Caffeine citrate) — Gennisium Pharma

  EMA authorised Gencebok, a caffeine citrate medicine by Gennisium Pharma, for the treatment of apnea (apnea of prematurity).

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• FDA approval · 2020-03-02
  FDA Approved: CAFFEINE CITRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for caffeine citrate by Hikma Pharmaceuticals USA Inc., updating the product’s labeling. The documen…

• FDA approval · 2019-12-16
  FDA Approved: CAFFEINE CITRATE — Original Application (Micro Labs Limited)

  FDA approved caffeine citrate from Micro Labs Limited through its Original Application for use as a respiratory stimulant in appropriate pat…

• FDA approval · 2017-12-14
  FDA Approved: CAFFEINE CITRATE — Original Application (Armas Pharmaceuticals Inc.)

  FDA approved the original application for caffeine citrate from Armas Pharmaceuticals Inc., a generic drug used to treat apnea of prematurit…

• FDA approval · 2017-01-02
  FDA Approved: CAFFEINE CITRATE — Supplemental Application (Sagent Pharmaceuticals)

  The FDA approved a supplemental application for caffeine citrate submitted by Sagent Pharmaceuticals. This action updates the product's labe…

• FDA approval · 2015-09-22
  FDA Approved: CAFFEINE CITRATE — Original Application (Eugia US LLC)

  FDA approved caffeine citrate from Eugia US LLC under its original application (ANDA205013), making caffeine citrate available as an approve…

• FDA approval · 2014-12-23
  FDA Approved: CAFFEINE CITRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for caffeine citrate from Hikma Pharmaceuticals USA Inc., resulting in labeling changes to the exist…

• FDA approval · 2013-02-25
  FDA Approved: CAFFEINE CITRATE — Supplemental Application (Sagent Pharmaceuticals)

  The FDA approved a supplemental application for caffeine citrate submitted by Sagent Pharmaceuticals, confirming labeling/approval for the p…

• FDA approval · 2012-08-29
  FDA Approved: CAFFEINE CITRATE — Original Application (Sagent Pharmaceuticals)

  FDA approved Sagent Pharmaceuticals' caffeine citrate as a generic drug for the treatment of apnea of prematurity under an Original Applicat…

• FDA approval · 2010-06-11
  FDA Approved: CAFFEINE CITRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for caffeine citrate from Hikma Pharmaceuticals USA Inc., enabling regulatory clearance for the supp…

• FDA approval · 2009-09-30
  FDA Approved: CAFFEINE CITRATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's caffeine citrate Original Application, a generic product for the treatment of apnea of prematurity. This m…

• FDA approval · 2008-01-31
  FDA Approved: CAFFEINE CITRATE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Fresenius Kabi USA, LLC's caffeine citrate product under an Original Application, adding a new caffeine citrate option to the m…

• FDA approval · 2007-07-20
  FDA Approved: CAFFEINE CITRATE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved the original application for caffeine citrate (generic) filed by Fresenius Kabi USA, LLC.

• FDA approval · 2006-09-21
  FDA Approved: CAFFEINE CITRATE — Original Application (Exela Pharma Sciences, LLC)

  FDA approves the original ANDA for caffeine citrate (Exela Pharma Sciences) as a generic drug.

• FDA approval · 2006-09-21
  FDA Approved: CAFFEINE CITRATE — Original Application (Exela Pharma Sciences, LLC)

  FDA approved caffeine citrate as a generic product under an Original Application by Exela Pharma Sciences, LLC.