Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Eton Pharmaceuticals, Inc.
080870465
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Amino GmbH
Eton Pharmaceuticals, Inc.
Eton Pharmaceuticals, Inc.
507524424
University of Iowa Pharmaceuticals
Eton Pharmaceuticals, Inc.
Eton Pharmaceuticals, Inc.
968854286
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Betaine Anhydrous
Product Details
NDC Product Code
71863-115Application Number
ANDA210508Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 18, 2023BetaineActive
Code: 3SCV180C9WClass: ACTIBQuantity: 1 g in 1 g