Orange Book product · Brand (NDA)
CYSTADANE
BETAINE
Brand (NDA)NDA 020576TE ABRX RECORDATI RARE
At a glance
Oct 25, 1996
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 25, 1996
30 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
BETAINE
Strength
1GM/SCOOPFUL
Dosage form
FOR SOLUTION
Route
ORAL
TE code
AB
Application
NDA 020576
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
