Orange Book product · Brand (NDA)
ARIMIDEX
ANASTROZOLE
At a glance
Dec 27, 1995
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 27, 1995
30 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
ANASTROZOLE
Strength
1MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020541
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.
- 2020ANASTROZOLEGeneric (ANDA)
ANDA 212434 · EUGIA PHARMA
- 2018ANASTROZOLEGeneric (ANDA)
ANDA 206037 · BEIJING YILING
- 2012ANASTROZOLEGeneric (ANDA)
ANDA 091242 · IMPAX LABS INC
- 2012ANASTROZOLEGeneric (ANDA)
ANDA 200654 · APOTEX INC
- 2011ANASTROZOLEGeneric (ANDA)
ANDA 091177 · SUN PHARM INDS LTD
- 2011ANASTROZOLEGeneric (ANDA)
ANDA 091331 · CHARTWELL MOLECULAR
- 2010ANASTROZOLEGeneric (ANDA)
ANDA 090568 · ACCORD HLTHCARE
- 2010ANASTROZOLEGeneric (ANDA)
ANDA 090732 · CHARTWELL RX
- 2010ANASTROZOLEGeneric (ANDA)
ANDA 091164 · CIPLA
- 2010ANASTROZOLEGeneric (ANDA)
ANDA 090088 · FRESENIUS KABI USA
- 2010ANASTROZOLEGeneric (ANDA)
ANDA 078485 · HIKMA
- 2010ANASTROZOLEGeneric (ANDA)
ANDA 078944 · KENTON
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.
