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FDA Approval

Betaine Anhydrous For Oral Solution

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

FDA Approval Summary

Company
Lukare Medical, LLC
DUNS: 062862393
Effective Date
May 1, 2020
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 Anhydrous For Oral Solution

Product Details

NDC Product Code
55792-002
Application Number
ANDA210508
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 1, 2020
BetaineActive
Code: 3SCV180C9WClass: ACTIBQuantity: 1 g in 1 g
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