Patent Ductus Arteriosus
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-02-16EMA Authorised: Ibuprofen Gen.Orph (Ibuprofen) — Gen.Orph
The European Medicines Agency authorised Ibuprofen Gen.Orph for the treatment of patent ductus arteriosus, with Gen.Orph as the marketing au…
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FDA approval · 2025-12-22FDA Approved: PROSTIN VR PEDIATRIC — Supplemental Application (Pharmacia & Upjohn Company LLC)
FDA approved a supplemental application for PROSTIN VR PEDIATRIC (alprostadil) from Pharmacia & Upjohn Company LLC, updating its pediatric u…
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EMA approval · 2025-11-25EMA Authorised: Pedea (Ibuprofen) — Recordati Rare Diseases
The EMA authorised Pedea (ibuprofen) from Recordati Rare Diseases for use in patent ductus arteriosus.
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FDA approval · 2025-02-24FDA Approved: INDOMETHACIN — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal Pharmaceuticals NY LLC's original application for Indomethacin, authorizing a generic version of the NSAID with the same…
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FDA approval · 2024-11-21FDA Approved: INDOMETHACIN — Supplemental Application (Chartwell RX, LLC)
The FDA approved a supplemental application for indomethacin submitted by Chartwell RX, LLC. This action represents an approved supplement t…
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FDA approval · 2024-11-21FDA Approved: INDOMETHACIN — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approves a supplemental application for Indomethacin from Amneal Pharmaceuticals LLC (ANDA 091549), authorizing a supplemental change to…
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FDA approval · 2023-09-07FDA Approved: INDOMETHACIN — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Indomethacin submitted by Amneal Pharmaceuticals LLC.
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FDA approval · 2021-04-28FDA Approved: INDOCIN — Supplemental Application (Zyla Life Sciences US LLC)
The FDA has approved a supplemental application for INDOCIN (indomethacin) by Zyla Life Sciences US LLC.
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FDA approval · 2021-04-28FDA Approved: INDOMETHACIN — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals LLC's supplemental application for Indomethacin, approving a generic Indomethacin product.
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FDA approval · 2021-04-28FDA Approved: INDOMETHACIN — Supplemental Application (XLCare Pharmaceuticals Inc.)
FDA approved a supplemental application for Indomethacin from XLCare Pharmaceuticals Inc. This approval updates the drug's existing FDA appr…
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FDA approval · 2021-04-26FDA Approved: INDOMETHACIN — Supplemental Application (XLCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for Indomethacin submitted by XLCare Pharmaceuticals Inc. under ANDA 091240.
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FDA approval · 2019-08-14FDA Approved: NEOPROFEN — Supplemental Application (Recordati Rare Diseases Inc.)
The FDA approved a supplemental application for NEOPROFEN (ibuprofen lysine) from Recordati Rare Diseases Inc., expanding its approved use o…
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FDA approval · 2019-07-18FDA Approved: PROSTIN VR PEDIATRIC — Supplemental Application (Pharmacia & Upjohn Company LLC)
The FDA approved a supplemental application for PROSTIN VR PEDIATRIC (alprostadil) submitted by Pharmacia & Upjohn Company LLC. The action p…
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FDA approval · 2017-06-22FDA Approved: INDOMETHACIN — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's Indomethacin generic under an Original Application; this entry records the approval status and product details.
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FDA approval · 2016-05-09FDA Approved: INDOMETHACIN — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approves Amneal's supplemental application for INDOMETHACIN, marking an approved modification to the product under an ANDA.
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FDA approval · 2016-05-09FDA Approved: INDOMETHACIN — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' supplemental application for Indomethacin, resulting in updated labeling for the product.
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FDA approval · 2015-03-09FDA Approved: EDEX — Supplemental Application (Endo USA, Inc.)
The FDA approved a supplemental application for EDEX (alprostadil) from Endo USA, Inc., indicating changes to the product’s labeling under N…
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FDA approval · 2014-10-16FDA Approved: INDOCIN — Supplemental Application (Zyla Life Sciences US LLC)
FDA approved a supplemental application for Indocin (indomethacin) submitted by Zyla Life Sciences US LLC.
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FDA approval · 2014-06-09FDA Approved: PROSTIN VR PEDIATRIC — Supplemental Application (Pharmacia & Upjohn Company LLC)
The FDA approved a supplemental application for PROSTIN VR PEDIATRIC (alprostadil) from Pharmacia & Upjohn Company LLC.
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FDA approval · 2012-09-28FDA Approved: INDOMETHACIN — Original Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals' indomethacin as an original ANDA (generic) application, making Indomethacin available as a generic …
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FDA approval · 2011-04-12FDA Approved: INDOMETHACIN — Original Application (XLCare Pharmaceuticals Inc.)
FDA approved the Indomethacin Original Application for XLCare Pharmaceuticals Inc., enabling a generic indomethacin product to reach the mar…
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FDA approval · 2010-03-17FDA Approved: INDOMETHACIN — Original Application (Fresenius Kabi USA, LLC)
The FDA approved an original NDA for indomethacin from Fresenius Kabi USA, LLC. The approval covers indications for inflammatory and musculo…
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FDA approval · 2009-03-06FDA Approved: INDOMETHACIN — Original Application (KVK-Tech, Inc.)
FDA approved an original application for Indomethacin by KVK-Tech, Inc., establishing a generic version of indomethacin. The approval signif…