Orange Book product · Brand (NDA)
ELIDEL
PIMECROLIMUS
Brand (NDA)NDA 021302TE ABRX BAUSCH
At a glance
Dec 13, 2001
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 13, 2001
24 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
PIMECROLIMUS
Strength
1%
Dosage form
CREAM
Route
TOPICAL
TE code
AB
Application
NDA 021302
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.
