Cystadane

Cystadane

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 767598352

Effective Date

March 5, 2018

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Betaine(1 g in 1 g)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

DUNS Number

767598352

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Orphan Europe SARL

Registrant

Orphan Europe SARL

DUNS Number

209989631

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

52276-401

Route of Administration

ORAL

Effective Date

March 5, 2018

Ingredients

Code: 3SCV180C9WClass: ACTIBQuantity: 1 g in 1 g