Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aphena Pharma Solutions - Tennessee, Inc.
Aphena Pharma Solutions - Tennessee, Inc.
128385585
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Premarin
Product Details
NDC Product Code
43353-688Application Number
NDA004782Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
July 18, 2012Conjugated estrogensActive
Code: IU5QR144QXClass: ACTIMQuantity: 0.625 mg in 1 1
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28Class: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9MClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT
Premarin
Product Details
NDC Product Code
43353-687Application Number
NDA004782Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
July 18, 2012TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28Class: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
Conjugated estrogensActive
Code: IU5QR144QXClass: ACTIMQuantity: 0.3 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9MClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2Class: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0WClass: IACT