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FDA Approval

CitraNatal Bloom

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

FDA Approval Summary

Company
Effective Date
January 5, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vitamin C(138 mg in 1 1)
Docusate(55 mg in 1 1)
Ferrous gluconate(13.2 mg in 1 1)
Folic acid(1.4 mg in 1 1)
Vitamin B12(16.8 ug in 1 1)
Iron(88.5 mg 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 Bloom

Product Details

NDC Product Code
0178-0813
Route of Administration
ORAL
Effective Date
January 5, 2024
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIHClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
MAGNESIUM SILICATEInactive
Code: 9B9691B2N9Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
VITAMIN A PALMITATEInactive
Code: 1D1K0N0VVCClass: IACT
ETHYL VANILLINInactive
Code: YC9ST449YJClass: IACT
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 138 mg in 1 1
DocusateActive
Code: F05Q2T2JA0Class: ACTIBQuantity: 55 mg in 1 1
Code: U1B11I423ZClass: ACTIMQuantity: 13.2 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 1.4 mg in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 16.8 ug in 1 1
IronActive
Code: 6WQ62TAQ6ZClass: ACTIMQuantity: 88.5 mg in 1 1
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