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FDA Approval

VERQUVO

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
October 26, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vericiguat(10 mg in 1 1)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

VERQUVO

Product Details

NDC Product Code
0006-5030
Application Number
NDA214377
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
October 26, 2023
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
Code: LV66ADM269Class: ACTIBQuantity: 10 mg in 1 1
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT

VERQUVO

Product Details

NDC Product Code
0006-5028
Application Number
NDA214377
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
October 26, 2023
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
Code: LV66ADM269Class: ACTIBQuantity: 2.5 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

VERQUVO

Product Details

NDC Product Code
0006-5029
Application Number
NDA214377
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
October 26, 2023
Code: LV66ADM269Class: ACTIBQuantity: 5 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
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VERQUVO - FDA Approval | MedPath