Orange Book product · Brand (NDA)
CYSTADROPS
CYSTEAMINE HYDROCHLORIDE
Brand (NDA)NDA 211302RX RECORDATI RARE
At a glance
Aug 19, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 19, 2020
5 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
CYSTEAMINE HYDROCHLORIDE
Strength
EQ 0.37% BASE
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 211302
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.
