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FDA Approval

CitraNatal 90 DHA

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

FDA Approval Summary

Company
Mission Pharmacal Company
DUNS: 008117095
Effective Date
January 8, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Riboflavin(3.4 mg in 1 1)
Vitamin C(120 mg in 1 1)
Iron(85 mg in 1 1)
Thiamine(3 mg in 1 1)
Nicotinamide(20 mg in 1 1)
Pyridoxine(20 mg in 1 1)
Folic acid(1 mg in 1 1)
Zinc oxide(25 mg in 1 1)
Cupric oxide(2 mg in 1 1)
Docusate(50 mg in 1 1)
Calcium citrate(159 mg in 1 1)
Thiamine(4.54 mg in 1 1)
Potassium Iodide(150 ug in 1 1)
Ferrous gluconate(5 mg in 1 1)
Vitamin D3(400 [iU] in 1 1)
alpha-Tocopherol acetate(30 [iU] in 1 1)

Registrants1

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

Mission Pharmacal Company

927726893

Manufacturing Establishments1

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

Mission Pharmacal Company

Mission Pharmacal Company

Mission Pharmacal Company

927726893

Products1

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

CitraNatal 90 DHA

Product Details

NDC Product Code
0178-0821
Route of Administration
ORAL
Effective Date
January 8, 2024
RiboflavinActive
Code: TLM2976OFRClass: ACTIBQuantity: 3.4 mg in 1 1
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 120 mg in 1 1
IronActive
Code: E1UOL152H7Class: ACTIBQuantity: 85 mg in 1 1
ThiamineActive
Code: X66NSO3N35Class: ACTIBQuantity: 3 mg in 1 1
NicotinamideActive
Code: 25X51I8RD4Class: ACTIBQuantity: 20 mg in 1 1
PyridoxineActive
Code: 68Y4CF58BVClass: ACTIBQuantity: 20 mg in 1 1
Folic acidActive
Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1
Zinc oxideActive
Code: SOI2LOH54ZClass: ACTIBQuantity: 25 mg in 1 1
Cupric oxideActive
Code: V1XJQ704R4Class: ACTIMQuantity: 2 mg in 1 1
DocusateActive
Code: F05Q2T2JA0Class: ACTIBQuantity: 50 mg in 1 1
Calcium citrateActive
Code: MLM29U2X85Class: ACTIRQuantity: 159 mg in 1 1
ThiamineActive
Code: 8K0I04919XClass: ACTIRQuantity: 4.54 mg in 1 1
Potassium IodideActive
Code: 1C4QK22F9JClass: ACTIBQuantity: 150 ug in 1 1
Ferrous gluconateActive
Code: U1B11I423ZClass: ACTIMQuantity: 5 mg in 1 1
Vitamin D3Active
Code: 9VU1KI44GPClass: ACTIBQuantity: 400 [iU] in 1 1
alpha-Tocopherol acetateActive
Code: 9E8X80D2L0Class: ACTIMQuantity: 30 [iU] in 1 1

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CitraNatal ®90DHA Carton

NDC: 0178-0821-30

Label

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION

One tablet and one capsule daily or as directed by a physician.

STORAGE AND HANDLING SECTION

STORAGE

Store at 20-25°C (68-77°F)

**NOTICE:**Contact with moisture can discolor or erode the tablet.

HOW SUPPLIED

Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC0178-0821-30

To reporta serious adverse event or obtain product information, call (210) 696-8400.

Please consultyour health care provider with any dietary concerns.

51072R1120

DHA capsules manufactured for:

MISSION PHARMACAL COMPANY

San Antonio, TX USA 78230 1355

Prenatal tablets manufactured by:

MISSION PHARMACAL COMPANY

San Antonio, TX USA 78230 1355

Ferr-Ease™

Dual-iron delivery

Trademark of Mission Pharmacal Company

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