Betaine Anhydrous for Oral Solution
These highlights do not include all the information needed to use BETAINE ANHYDROUS FOR ORAL SOLUTION safely and effectively. See full prescribing information for BETAINE ANHYDROUS FOR ORAL SOLUTION. Initial U.S. Approval 1996
Approved
Approval ID
5e283511-04ae-4698-b368-8446385990e8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2022
Manufacturers
FDA
OAKRUM PHARMA, LLC
DUNS: 081507685
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Betaine Anhydrous
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72647-900
Application NumberANDA214864
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betaine Anhydrous
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2022
FDA Product Classification
INGREDIENTS (1)
BetaineActive
Quantity: 1 g in 1 g
Code: 3SCV180C9W
Classification: ACTIB