Organon & Co.
Overview
Organon & Co. is a global healthcare company dedicated to improving the health of women throughout their lives. It was spun off from Merck & Co., Inc. in 2021. The company focuses on the innovation of women’s health solutions and provides a wide range of therapies in reproductive health, heart disease, and more.
Therapeutic areas
API / Drug Master Files
Organon & Co. holds 0 active (56 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- 2-METHOXYESTRADIOLInactive2007-09-06
- 16-ALPHA-HYDROXYPREDNISOLONE (INTERMEDIATE)Inactive2006-06-07
- NORGESTIMATEInactive2006-04-06
- FENTANYL CITRATEInactive2006-01-03
- NALTREXONEInactive2004-07-20
- OXANDROLONEInactive2004-06-09
- ANDROSTANOLONEInactive2003-10-15
- ESTERIFIED ESTROGENS TYPE BAInactive2002-12-06
- HEPARIN SODIUM IIIInactive2002-11-11
- ESTRADIOL BENZOATEInactive2000-10-11
- DEHYDROISOANDROSTERONE POLYMORPH IInactive1999-07-12
- TIBOLONEInactive1998-12-14
- PORCINE INSULIN HIGHLY PURIFIEDInactive1998-07-27
- NORGESTOMETInactive1997-01-23
- MEGESTROL ACETATEInactive1996-10-02
Showing 15 of 56 Drug Master Files.
FDA compliance signals
3 FDA enforcement records linked to this company.
- recall — Class III2024-06-19
Defective Container
- recall — Class III2024-06-19
Defective Container
- recall — Class III2024-06-19
Defective Container
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