Cystadane
These highlights do not include all the information needed to use Cystadane safely and effectively. See full prescribing information for Cystadane. Cystadane (betaine anhydrous for oral solution) powderInitial U.S. Approval: 1996
Approved
Approval ID
84f7c21f-d0af-4ae6-9cd5-d5af96ade329
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2015
Manufacturers
FDA
Rare Disease Therapeutics, Inc.
DUNS: 966133100
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
betaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66621-4000
Application NumberNDA020576
Product Classification
M
Marketing Category
C73594
G
Generic Name
betaine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2010
FDA Product Classification
INGREDIENTS (1)
BETAINEActive
Quantity: 6 g in 1 1
Code: 3SCV180C9W
Classification: ACTIB