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FDA Approval

Prenate Mini

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

FDA Approval Summary

Company
Effective Date
January 23, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Biotin(280 ug in 1 1)
Calcium carbonate(80 mg in 1 1)
Iron(9 mg in 1 1)
Potassium Iodide(150 ug in 1 1)
Magnesium oxide(25 mg in 1 1)
Doconexent(350 mg in 1 1)
Lowbush blueberry(25 mg in 1 1)
Levomefolic acid(600 ug in 1 1)
Vitamin C(60 mg in 1 1)
Vitamin D3(1000 [iU] in 1 1)
Pyridoxine(26 mg in 1 1)
Folic acid(400 ug in 1 1)
Vitamin B12(13 ug in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Avion Pharmaceuticals, LLC

Avion Pharmaceuticals, LLC

040348516

Products1

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

Prenate Mini

Product Details

NDC Product Code
75854-315
Route of Administration
ORAL
Effective Date
January 7, 2021
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 280 ug in 1 1
Code: H0G9379FGKClass: ACTIMQuantity: 80 mg in 1 1
Code: H7426RGB3LClass: ACTIMQuantity: 9 mg in 1 1
IronActive
Code: E1UOL152H7Class: ACTIMQuantity: 9 mg in 1 1
Code: 1C4QK22F9JClass: ACTIMQuantity: 150 ug in 1 1
Code: 3A3U0GI71GClass: ACTIMQuantity: 25 mg in 1 1
Code: ZAD9OKH9JCClass: ACTIBQuantity: 350 mg in 1 1
Code: G90PX41VP0Class: ACTIBQuantity: 25 mg in 1 1
Code: 8S95DH25XCClass: ACTIBQuantity: 600 ug in 1 1
FISH OILInactive
Code: XGF7L72M0FClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2VClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
CORN OILInactive
Code: 8470G57WFMClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 60 mg in 1 1
Code: 1C6V77QF41Class: ACTIBQuantity: 1000 [iU] in 1 1
Code: 68Y4CF58BVClass: ACTIBQuantity: 26 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 400 ug in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 13 ug in 1 1
Code: WR1WPI7EW8Class: ACTIMQuantity: 10 [iU] in 1 1
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