Manufacturing Establishments (1)
Patheon Pharmaceuticals Inc
Adhera Therapeutics, Inc.
005286822
Products (3)
Prestalia
72931-011
NDA205003
NDA (C73594)
ORAL
August 31, 2019
PerindoprilActive
Code: TFT5IM1KGBClass: ACTIBQuantity: 7 mg in 1 1
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
AmlodipineActive
Code: 864V2Q084HClass: ACTIMQuantity: 5 mg in 1 1
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Prestalia
72931-010
NDA205003
NDA (C73594)
ORAL
August 31, 2019
PerindoprilActive
Code: TFT5IM1KGBClass: ACTIBQuantity: 3.5 mg in 1 1
AmlodipineActive
Code: 864V2Q084HClass: ACTIMQuantity: 2.5 mg in 1 1
magnesium stearateInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Prestalia
72931-012
NDA205003
NDA (C73594)
ORAL
August 31, 2019
PerindoprilActive
Code: TFT5IM1KGBClass: ACTIBQuantity: 14 mg in 1 1
AmlodipineActive
Code: 864V2Q084HClass: ACTIMQuantity: 10 mg in 1 1
magnesium stearateInactive
Code: 70097M6I30Class: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT