Betaine Anhydrous
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. BETAINE ANHYDROUS FOR ORAL SOLUTION Initial U.S. Approval: 1996
Approved
Approval ID
ee8a95c3-df9f-6e55-e053-2a95a90ab17b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
Eton Pharmaceuticals, Inc.
DUNS: 080870465
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 Code71863-115
Application NumberANDA210508
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betaine Anhydrous
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (1)
BETAINEActive
Quantity: 1 g in 1 g
Code: 3SCV180C9W
Classification: ACTIB