FDA NDA · NDA020576

CYSTADANE

betaine

Sponsor: RECORDATI RARE

APPLICATION

NDA020576

TYPE

NDA

ORIGINAL APPROVAL

1996-10-25

LATEST ACTION

2018-11-06

ROUTE

ORAL

DOSAGE FORM

FOR SOLUTION

MARKETING STATUS

Prescription

Products

CYSTADANE · ReferencePrescription

BETAINE 1GM/SCOOPFUL · FOR SOLUTION · ORAL

2018-11-06Labeling · Supplement 14 · standard — Label ↗AP

2010-04-05Labeling · Supplement 10 · standard — Label ↗AP

2006-02-17Labeling · Supplement 8 · standard — Letter ↗AP

2000-08-25Manufacturing (CMC) · Supplement 5 · priorityAP

2000-01-21Manufacturing (CMC) · Supplement 4 · priorityAP

1999-03-16Labeling · Supplement 3 · standardAP

1998-08-13Manufacturing (CMC) · Supplement 2 · priorityAP

1998-05-05Labeling · Supplement 1 · standardAP

1996-10-25Type 1 - New Molecular Entity · Original · priority — Review ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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