Prochieve
Prochieve 4%Prochieve 8%(progesterone gel)
Approved
Approval ID
9f8dc923-65d7-42ff-b718-97e7a7e87822
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 19, 2009
Manufacturers
FDA
Columbia Laboratories
DUNS: 177253754
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
progesterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55056-0406
Application NumberNDA020701
Product Classification
M
Marketing Category
C73594
G
Generic Name
progesterone
Product Specifications
Route of AdministrationVAGINAL
Effective DateNovember 19, 2009
FDA Product Classification
INGREDIENTS (9)
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
progesteroneActive
Quantity: 45 mg in 1.125 g
Code: 4G7DS2Q64Y
Classification: ACTIB
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
polycarbophilInactive
Code: W25LM17A4W
Classification: IACT
carbomer 934Inactive
Code: Z135WT9208
Classification: IACT
hydrogenated palm oilInactive
Code: 257THB963H
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
sorbic acidInactive
Code: X045WJ989B
Classification: IACT
progesterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55056-1601
Application NumberNDA020701
Product Classification
M
Marketing Category
C73594
G
Generic Name
progesterone
Product Specifications
Route of AdministrationVAGINAL
Effective DateNovember 19, 2009
FDA Product Classification
INGREDIENTS (9)
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
progesteroneActive
Quantity: 90 mg in 1.125 g
Code: 4G7DS2Q64Y
Classification: ACTIB
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
polycarbophilInactive
Code: W25LM17A4W
Classification: IACT
carbomer 934Inactive
Code: Z135WT9208
Classification: IACT
hydrogenated palm oilInactive
Code: 257THB963H
Classification: IACT
sorbic acidInactive
Code: X045WJ989B
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT