Orange Book product · Brand (NDA)
STERITALC
TALC
Brand (NDA)NDA 205555RX NOVATECH SA
At a glance
May 01, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 01, 2017
9 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
TALC
Strength
4GM/VIAL
Dosage form
POWDER
Route
INTRAPLEURAL
TE code
Not listed
Application
NDA 205555
Product number
003
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.
