Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Rare Disease Therapeutics, Inc.
966133100
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Rare Disease Therapeutics, Inc.
Rare Disease Therapeutics, Inc.
Rare Disease Therapeutics, Inc.
966133100
Ropack Pharmaceutical
Rare Disease Therapeutics, Inc.
Rare Disease Therapeutics, Inc.
209989631
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cystadane
Product Details
NDC Product Code
66621-4000Application Number
NDA020576Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 10, 2010BetaineActive
Code: 3SCV180C9WClass: ACTIBQuantity: 6 g in 1 1