Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Columbia Laboratories Inc
Columbia Laboratories, Inc.
177253754
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Crinone
Product Details
NDC Product Code
55056-0808Application Number
NDA020701Marketing Category
NDA (C73594)Route of Administration
VAGINALEffective Date
November 19, 2009ProgesteroneActive
Code: 4G7DS2Q64YClass: ACTIBQuantity: 45 mg in 1.125 g
glycerinInactive
Code: PDC6A3C0OXClass: IACT
carbomer 934Inactive
Code: Z135WT9208Class: IACT
mineral oilInactive
Code: T5L8T28FGPClass: IACT
polycarbophilInactive
Code: W25LM17A4WClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
palm oilInactive
Code: 5QUO05548ZClass: IACT
sorbic acidInactive
Code: X045WJ989BClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
Crinone
Product Details
NDC Product Code
55056-0818Application Number
NDA020701Marketing Category
NDA (C73594)Route of Administration
VAGINALEffective Date
November 19, 2009glycerinInactive
Code: PDC6A3C0OXClass: IACT
ProgesteroneActive
Code: 4G7DS2Q64YClass: ACTIBQuantity: 90 mg in 1.125 g
mineral oilInactive
Code: T5L8T28FGPClass: IACT
polycarbophilInactive
Code: W25LM17A4WClass: IACT
carbomer 934Inactive
Code: Z135WT9208Class: IACT
sorbic acidInactive
Code: X045WJ989BClass: IACT
palm oilInactive
Code: 5QUO05548ZClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
Crinone
Product Details
NDC Product Code
55056-0806Application Number
NDA020701Marketing Category
NDA (C73594)Route of Administration
VAGINALEffective Date
November 19, 2009ProgesteroneActive
Code: 4G7DS2Q64YClass: ACTIBQuantity: 90 mg in 1.125 g
mineral oilInactive
Code: T5L8T28FGPClass: IACT
glycerinInactive
Code: PDC6A3C0OXClass: IACT
sorbic acidInactive
Code: X045WJ989BClass: IACT
polycarbophilInactive
Code: W25LM17A4WClass: IACT
carbomer 934Inactive
Code: Z135WT9208Class: IACT
palm oilInactive
Code: 5QUO05548ZClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT