Orange Book product · Brand (NDA)
TALC
TALC
Brand (NDA)NDA 021388RX SCIARRA LABS
At a glance
Dec 15, 2003
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 15, 2003
22 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
TALC
Strength
5GM/BOT
Dosage form
POWDER
Route
INTRAPLEURAL
TE code
Not listed
Application
NDA 021388
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.
