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FDA Approval

Reaphirm Plant Source DHA

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

FDA Approval Summary

Company
Effective Date
November 28, 2011
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vitamin A(1100 [iU] in 1 1)
Vitamin E(20 [iU] in 1 1)
Vitamin C(30 mg in 1 1)
Thiamine(1.6 mg in 1 1)
Riboflavin(1.8 mg in 1 1)
Niacin(15 mg in 1 1)
Pyridoxine(2.5 mg in 1 1)
Vitamin B12(.012 mg in 1 1)
Folic acid(1 mg in 1 1)
Iopromide(0.150 mg in 1 1)
Magnesium(20 mg in 1 1)
Zinc(25 mg in 1 1)
Copper(2 mg in 1 1)
Vitamin D3(1000 [iU] in 1 1)
Omega-3 fatty acids(200 mg in 1 1)
Iron(29 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Everett Laboratories, Inc.

071170534

Products1

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

Reaphirm Plant Source DHA

Product Details

NDC Product Code
0642-3010
Route of Administration
ORAL
Effective Date
November 28, 2011
Vitamin AActive
Code: 81G40H8B0TClass: ACTIMQuantity: 1100 [iU] in 1 1
Sodium ThiosulfateInactive
Code: HX1032V43MClass: IACT
TocopherolInactive
Code: R0ZB2556P8Class: IACT
CaramelInactive
Code: T9D99G2B1RClass: IACT
Vitamin EActive
Code: H4N855PNZ1Class: ACTIMQuantity: 20 [iU] in 1 1
Corn OilInactive
Code: 8470G57WFMClass: IACT
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 30 mg in 1 1
ThiamineActive
Code: 8K0I04919XClass: ACTIBQuantity: 1.6 mg in 1 1
Code: TLM2976OFRClass: ACTIMQuantity: 1.8 mg in 1 1
NiacinActive
Code: 2679MF687AClass: ACTIMQuantity: 15 mg in 1 1
Code: 68Y4CF58BVClass: ACTIMQuantity: 2.5 mg in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: .012 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1
IopromideActive
Code: 9679TC07X4Class: ACTIBQuantity: 0.150 mg in 1 1
MagnesiumActive
Code: I38ZP9992AClass: ACTIMQuantity: 20 mg in 1 1
ZincActive
Code: J41CSQ7QDSClass: ACTIMQuantity: 25 mg in 1 1
CopperActive
Code: 789U1901C5Class: ACTIMQuantity: 2 mg in 1 1
Code: 9VU1KI44GPClass: ACTIMQuantity: 1000 [iU] in 1 1
Code: 71M78END5SClass: ACTIMQuantity: 200 mg in 1 1
GelatinInactive
Code: 2G86QN327LClass: IACT
SorbitolInactive
Code: 506T60A25RClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
GlycerinInactive
Code: PDC6A3C0OXClass: IACT
Soybean OilInactive
Code: 241ATL177AClass: IACT
Yellow WaxInactive
Code: 2ZA36H0S2VClass: IACT
Anhydrous Dibasic Calcium PhosphateInactive
Code: L11K75P92JClass: IACT
Lecithin, SoybeanInactive
Code: 1DI56QDM62Class: IACT
Titanium DioxideInactive
Code: 15FIX9V2JPClass: IACT
Sunflower OilInactive
Code: 3W1JG795YIClass: IACT
Ascorbyl palmitateInactive
Code: QN83US2B0NClass: IACT
FD&C Blue NO. 1Inactive
Code: H3R47K3TBDClass: IACT
IronActive
Code: E1UOL152H7Class: ACTIBQuantity: 29 mg in 1 1
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