Orange Book product · Brand (NDA)
HALOG
HALCINONIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AT
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
HALCINONIDE
Strength
0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
TOPICAL
TE code
AT
Application
NDA 017823
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- —HALOGBrand (NDA)
NDA 017556 · SUN PHARM INDS INC
- —HALOGBrand (NDA)
NDA 017818 · WESTWOOD SQUIBB
- —HALOG-EBrand (NDA)
NDA 018234 · SUN PHARM INDS INC
- —HALOGBrand (NDA)
NDA 018125 · BRISTOL MYERS SQUIBB
- —HALOGBrand (NDA)
NDA 017824 · SUN PHARM INDS INC
- 2024HALCINONIDEGeneric (ANDA)
ANDA 217671 · ENCUBE
- 2021HALCINONIDEGeneric (ANDA)
ANDA 214723 · CHARTWELL RX
- 2019HALCINONIDEGeneric (ANDA)
ANDA 211027 · MYLAN
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.
