Orange Book product · Brand (NDA)
ALDARA
IMIQUIMOD
At a glance
Feb 27, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 27, 1997
29 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
IMIQUIMOD
Strength
5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 020723
Product number
001
Marketing status
DISCN
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.
- 2011ZYCLARABrand (NDA)
NDA 022483 · BAUSCH
- 2021IMIQUIMODGeneric (ANDA)
ANDA 205971 · TARO
- 2014IMIQUIMODGeneric (ANDA)
ANDA 202002 · STRIDES PHARMA
- 2012IMIQUIMODGeneric (ANDA)
ANDA 091308 · APOTEX INC
- 2012IMIQUIMODGeneric (ANDA)
ANDA 201994 · GLENMARK PHARMS
- 2011IMIQUIMODGeneric (ANDA)
ANDA 200481 · COSETTE
- 2011IMIQUIMODGeneric (ANDA)
ANDA 200173 · TARO
- 2011IMIQUIMODGeneric (ANDA)
ANDA 091044 · ENCUBE
- 2010IMIQUIMODGeneric (ANDA)
ANDA 078837 · PADAGIS ISRAEL
- 2010IMIQUIMODGeneric (ANDA)
ANDA 078548 · FOUGERA PHARMS
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.
