Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Sharp Packaging Services, LLC
Mayne Pharma
143696495
Catalent Pharma Solutions, LLC
Mayne Pharma
051762268
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bijuva
Product Details
NDC Product Code
68308-750Application Number
NDA210132Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
November 28, 2023ProgesteroneActive
Code: 4G7DS2Q64YClass: ACTIBQuantity: 100 mg in 1 1
GlycerinInactive
Code: PDC6A3C0OXClass: IACT
Medium-Chain TriglyceridesInactive
Code: C9H2L21V7UClass: IACT
Lecithin, SoybeanInactive
Code: 1DI56QDM62Class: IACT
EstradiolActive
Code: 4TI98Z838EClass: ACTIBQuantity: 1 mg in 1 1
GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85Class: IACT
Lauroyl Peg-32 GlyceridesInactive
Code: H5ZC52369MClass: IACT
Gelatin Type B Bovine (200 Bloom)Inactive
Code: A7JR5F8DLHClass: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327LClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOAClass: IACT
AlcoholInactive
Code: 3K9958V90MClass: IACT
Ethyl AcetateInactive
Code: 76845O8NMZClass: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3Class: IACT
Polyvinyl Acetate PhthalateInactive
Code: 58QVG85GW3Class: IACT
AmmoniaInactive
Code: 5138Q19F1XClass: IACT
Bijuva
Product Details
NDC Product Code
68308-751Application Number
NDA210132Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
November 28, 2023ProgesteroneActive
Code: 4G7DS2Q64YClass: ACTIBQuantity: 100 mg in 1 1
Lauroyl Peg-32 GlyceridesInactive
Code: H5ZC52369MClass: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327LClass: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT
AlcoholInactive
Code: 3K9958V90MClass: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3Class: IACT
Ethyl AcetateInactive
Code: 76845O8NMZClass: IACT
EstradiolActive
Code: 4TI98Z838EClass: ACTIBQuantity: 0.5 mg in 1 1
GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85Class: IACT
Gelatin Type B Bovine (200 Bloom)Inactive
Code: A7JR5F8DLHClass: IACT
GlycerinInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOAClass: IACT
Polyvinyl Acetate PhthalateInactive
Code: 58QVG85GW3Class: IACT
AmmoniaInactive
Code: 5138Q19F1XClass: IACT
Medium-Chain TriglyceridesInactive
Code: C9H2L21V7UClass: IACT
Lecithin, SoybeanInactive
Code: 1DI56QDM62Class: IACT