MedPath

Biopar delta-FORTE

-FORTE

Approved
Approval ID

ce7d1f45-0e38-48c5-abf6-b229c6b2e9b3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 18, 2022

Manufacturers
FDA

Jaymac Pharma

DUNS: 830767260

Products 1

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

1 NF Units, 50 mcg CBl, 2.5 mg F-THf, 1 mg PteGlu-, 7 mg Me-THf

PRODUCT DETAILS

NDC Product Code64661-793
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateJuly 18, 2022
Generic Name1 NF Units, 50 mcg CBl, 2.5 mg F-THf, 1 mg PteGlu-, 7 mg Me-THf

INGREDIENTS (30)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
OLIVE OILInactive
Code: 6UYK2W1W1E
Classification: IACT
PHOSPHATIDYL SERINEInactive
Quantity: 12 mg in 1 1
Code: 394XK0IH40
Classification: IACT
INTRINSIC FACTORActive
Quantity: 50 mg in 1 1
Code: 70BT6OQT2Q
Classification: ACTIB
COBALAMINActive
Quantity: 50 ug in 1 1
Code: 8406EY2OQA
Classification: ACTIB
COBAMAMIDEActive
Quantity: 50 ug in 1 1
Code: F0R1QK73KB
Classification: ACTIM
levoLEUCOVORINActive
Quantity: 2.5 mg in 1 1
Code: 990S25980Y
Classification: ACTIB
DIHYDROFOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: KXP0KNM559
Classification: ACTIM
LEVOMEFOLATE MAGNESIUMActive
Quantity: 7 mg in 1 1
Code: 1VZZ62R081
Classification: ACTIM
FERROUS CYSTEINE GLYCINATEInactive
Quantity: 13.6 mg in 1 1
Code: 8B4OP7RK5N
Classification: IACT
1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUMInactive
Quantity: 6.4 mg in 1 1
Code: 6WJM73T46K
Classification: IACT
1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUMInactive
Quantity: 800 ug in 1 1
Code: 9ABD9DRK7B
Classification: IACT
PYRIDOXAL PHOSPHATE ANHYDROUSInactive
Quantity: 25 ug in 1 1
Code: F06SGE49M6
Classification: IACT
FLAVIN ADENINE DINUCLEOTIDEInactive
Quantity: 25 ug in 1 1
Code: ZC44YTI8KK
Classification: IACT
NADHInactive
Quantity: 25 ug in 1 1
Code: 4J24DQ0916
Classification: IACT
COCARBOXYLASEInactive
Quantity: 25 ug in 1 1
Code: Q57971654Y
Classification: IACT
MAGNESIUM ASCORBATEInactive
Quantity: 24 mg in 1 1
Code: 0N1G678593
Classification: IACT
ZINC ASCORBATEInactive
Quantity: 1 mg in 1 1
Code: 9TI35313XW
Classification: IACT
RIBOFLAVINInactive
Quantity: 5 mg in 1 1
Code: TLM2976OFR
Classification: IACT
MAGNESIUM L-THREONATEInactive
Quantity: 1 mg in 1 1
Code: 1Y26ZZ0OTM
Classification: IACT
BETAINEInactive
Quantity: 500 ug in 1 1
Code: 3SCV180C9W
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 1.83 mg in 1 1
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATEInactive
Quantity: 3.67 mg in 1 1
Code: 1Q73Q2JULR
Classification: IACT
ANNATTOInactive
Code: 6PQP1V1B6O
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LECITHIN, SUNFLOWERInactive
Code: 834K0WOS5G
Classification: IACT
PIPERINEInactive
Code: U71XL721QK
Classification: IACT
UBIDECARENONEInactive
Code: EJ27X76M46
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT

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Biopar delta-FORTE - FDA Drug Approval Details