Postpartum Hemorrhage

• FDA approval · 2024-04-03
  FDA Approved: CARBOPROST TROMETHAMINE — Original Application (Micro Labs Limited)

  FDA approved the original application for Carboprost Tromethamine from Micro Labs Limited (ANDA 218013), enabling a generic version of this …

• FDA approval · 2024-01-25
  FDA Approved: CARBOPROST TROMETHAMINE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approves ANI Pharmaceuticals' original application for a generic carboprost tromethamine product, used to induce abortion and to treat p…

• FDA approval · 2023-08-07
  FDA Approved: CARBOPROST TROMETHAMINE — Original Application (Hospira, Inc.)

  FDA approved Hospira's generic carboprost tromethamine under an Original Application (ANDA) for postpartum hemorrhage and termination of pre…

• FDA approval · 2023-07-25
  FDA Approved: CARBOPROST TROMETHAMINE — Original Application (Xellia Pharmaceuticals USA LLC)

  The FDA approved an original ANDA for a generic carboprost tromethamine from Xellia Pharmaceuticals USA LLC, marking a new generic product i…

• FDA approval · 2023-06-15
  FDA Approved: CARBOPROST TROMETHAMINE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's original application for Carboprost Tromethamine injection (generic) to treat postpartum hemo…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2023-05-25
  FDA Approved: CARBOPROST TROMETHAMINE — Original Application (Eugia US LLC)

  FDA approved the original ANDA for Carboprost Tromethamine from Eugia US LLC, authorizing its generic product for obstetric indications incl…

• FDA approval · 2023-05-19
  FDA Approved: CARBOPROST TROMETHAMINE — Original Application (SOLA Pharmaceuticals, LLC)

  FDA approved an original application for Carboprost tromethamine by SOLA Pharmaceuticals, LLC, a generic prostaglandin used to terminate pre…

• FDA approval · 2022-06-23
  FDA Approved: TRANEXAMIC ACID — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for tranexamic acid submitted by Mylan Institutional LLC. This action authorizes the continued comme…

• FDA approval · 2021-01-15
  FDA Approved: METHYLERGONOVINE MALEATE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved an original application for methyl ergonovine maleate (methylergonovine maleate) by Rising Pharma Holdings, Inc., enabling its …

• FDA approval · 2020-06-25
  FDA Approved: TRANEXAMIC ACID — Supplemental Application (XGen Pharmaceuticals DJB, Inc.)

  The FDA approved a supplemental application for tranexamic acid submitted by XGen Pharmaceuticals DJB, Inc. under an ANDA, indicating regula…

• FDA approval · 2020-05-01
  FDA Approved: METHYLERGONOVINE MALEATE — Original Application (Volley Pharmaceuticals, LLC)

  FDA approved a generic version of methylergonovine maleate (brand Methergine) from Volley Pharmaceuticals through an Original Application (A…

• FDA approval · 2019-07-02
  FDA Approved: CARBOPROST TROMETHAMINE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved Dr. Reddy's Laboratories' original abbreviated new drug application for carboprost tromethamine, enabling its generic use for o…

• FDA approval · 2019-03-20
  FDA Approved: METHYLERGONOVINE MALEATE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's generic methylergonovine maleate (ANDA 211455) for prevention of postpartum hemorrhage due to uterine atony after delive…

• FDA approval · 2018-09-10
  FDA Approved: METHYLERGONOVINE MALEATE — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's generic methyl ergonovine maleate (ANDA 211483) as a uterotonic to help control postpartum …

• FDA approval · 2018-05-15
  FDA Approved: METHYLERGONOVINE MALEATE — Original Application (Granules Pharmaceuticals Inc.)

  FDA approved Granules Pharmaceuticals Inc.'s original application for methylergonovine maleate, a generic medication used to prevent postpar…

• FDA approval · 2015-06-19
  FDA Approved: HEMABATE — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental application for Hemabate (carboprost tromethamine) submitted by Pharmacia & Upjohn Company LLC. The approval…

• FDA approval · 2014-10-02
  FDA Approved: PITOCIN — Supplemental Application (Par Health USA, LLC)

  The FDA granted a supplemental approval for PITOCIN (oxytocin) from Par Health USA, LLC.

• FDA approval · 2014-06-18
  FDA Approved: PITOCIN — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for Pitocin (oxytocin) submitted by Par Health USA, LLC.

• FDA approval · 2014-06-09
  FDA Approved: HEMABATE — Supplemental Application (Pharmacia & Upjohn Company LLC)

  FDA approved a supplemental application for HEMABATE (carboprost tromethamine) from Pharmacia & Upjohn Company LLC.

• FDA approval · 2013-12-11
  FDA Approved: HEMABATE — Supplemental Application (Pharmacia & Upjohn Company LLC)

  FDA approved a supplemental application for Hemabate (carboprost tromethamine) submitted by Pharmacia & Upjohn Company LLC.

• FDA approval · 2013-03-29
  FDA Approved: METHERGINE — Supplemental Application (Lupin Pharmaceuticals,Inc.)

  FDA approved a supplemental application for METHERGINE (methylergonovine maleate) submitted by Lupin Pharmaceuticals, Inc. The approval upda…

• FDA approval · 2013-02-13
  FDA Approved: OXYTOCIN — Original Application (West-Ward Pharmaceuticals Corp)

  FDA approves the original application for an Oxytocin injectable from West-Ward Pharmaceuticals Corp, making a generic oxytocin product avai…

• FDA approval · 2013-01-31
  FDA Approved: METHYLERGONOVINE MALEATE — Supplemental Application (Pharmacist Pharmaceutical, LLC)

  FDA approved a supplemental application for METHYLERGONOVINE MALEATE from Pharmacist Pharmaceutical, LLC. This action approves the supplemen…

• FDA approval · 2012-03-02
  FDA Approved: TRANEXAMIC ACID — Original Application (Fresenius Kabi USA, LLC)

  FDA approves the original application for tranexamic acid as a generic product from Fresenius Kabi USA, LLC. This marks the entry of a gener…

• FDA approval · 2011-05-02
  FDA Approved: METHERGINE — Original Application (Lupin Pharmaceuticals,Inc.)

  FDA approved Lupin Pharmaceuticals' original ANDA for Methergine (methylergonovine maleate), a generic drug indicated for preventing and tre…