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FDA Approval

Betaine

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

FDA Approval Summary

Company
Effective Date
November 4, 2022
Labeling Type
Human Prescription Drug Label
Betaine(1 g in 1 g)

Products1

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

Betaine

Product Details

NDC Product Code
0713-0352
Application Number
ANDA214864
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 4, 2022
BetaineActive
Code: 3SCV180C9WClass: ACTIBQuantity: 1 g in 1 g
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