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FDA Approval

CitraNatal Harmony

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
May 3, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Calcium citrate(100 mg in 1 1)
Iron(27 mg in 1 1)
Vitamin D3(400 [iU] in 1 1)
Pyridoxine(25 mg in 1 1)
Doconexent(250 mg in 1 1)
Docusate(50 mg in 1 1)
Folic acid(1 mg in 1 1)
DL-alpha-Tocopherol(30 [iU] in 1 1)

Manufacturing Establishments2

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

Accucaps Industries Ltd.

MISSION PHARMACAL COMPANY

248441727

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 Harmony

Product Details

NDC Product Code
0178-0812
Route of Administration
ORAL
Effective Date
May 3, 2010
Calcium citrateActive
Code: MLM29U2X85Class: ACTIBQuantity: 100 mg in 1 1
IronActive
Code: 6WQ62TAQ6ZClass: ACTIBQuantity: 27 mg in 1 1
Vitamin D3Active
Code: 1C6V77QF41Class: ACTIBQuantity: 400 [iU] in 1 1
PyridoxineActive
Code: 68Y4CF58BVClass: ACTIBQuantity: 25 mg in 1 1
DoconexentActive
Code: ZAD9OKH9JCClass: ACTIBQuantity: 250 mg in 1 1
DocusateActive
Code: F05Q2T2JA0Class: ACTIBQuantity: 50 mg in 1 1
Folic acidActive
Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1
DL-alpha-TocopherolActive
Code: 7QWA1RIO01Class: ACTIBQuantity: 30 [iU] in 1 1
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