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Myhephron

Mynephron - 185

Approved
Approval ID

5fc73ffc-5d0e-4d94-b4e5-8043d58fb59b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 2, 2016

Manufacturers
FDA

Martin Ekwealor Pharmaceu

DUNS: 010759905

Products 1

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

ASCORBIC ACID, FOLATE, NIACIN, THIAMINE, RIBOFLAVIN, PYRIDOXINE, CYANOCOBALAMIN, PANTOTHENIC ACID, BIOTIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code58607-185
Product Classification
G
Generic Name
ASCORBIC ACID, FOLATE, NIACIN, THIAMINE, RIBOFLAVIN, PYRIDOXINE, CYANOCOBALAMIN, PANTOTHENIC ACID, BIOTIN
Product Specifications
Route of AdministrationORAL
Effective DateAugust 4, 2016
FDA Product Classification

INGREDIENTS (14)

ASCORBIC ACIDActive
Quantity: 100 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
PYRIDOXINEActive
Quantity: 10 mg in 1 1
Code: KV2JZ1BI6Z
Classification: ACTIB
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
THIAMINEActive
Quantity: 1.5 mg in 1 1
Code: X66NSO3N35
Classification: ACTIB
NIACINActive
Quantity: 20 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
RIBOFLAVINActive
Quantity: 1.7 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 6 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
PANTOTHENIC ACIDActive
Quantity: 5 mg in 1 1
Code: 19F5HK2737
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
BIOTINActive
Quantity: 150 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURETH-3 SULFATEInactive
Code: BPV390UAP0
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT

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Myhephron - FDA Drug Approval Details