Orange Book product · Brand (NDA)
TENORMIN
ATENOLOL
At a glance
Sep 13, 1989
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 13, 1989
37 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ATENOLOL
Strength
0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019058
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.
- 1990TENORMINBrand (NDA)
NDA 018240 · TWI PHARMS
- 2019ATENOLOLGeneric (ANDA)
ANDA 213136 · UNICHEM
- 2009ATENOLOLGeneric (ANDA)
ANDA 078254 · NORTHSTAR HLTHCARE
- 2007ATENOLOLGeneric (ANDA)
ANDA 078512 · AUROBINDO PHARMA
- 2007ATENOLOLGeneric (ANDA)
ANDA 078210 · SUN PHARM INDS INC
- 2006ATENOLOLGeneric (ANDA)
ANDA 077877 · IPCA LABS LTD
- 2006ATENOLOLGeneric (ANDA)
ANDA 077443 · UNIQUE
- 2005ATENOLOLGeneric (ANDA)
ANDA 076900 · ZYDUS PHARMS USA
- 2004ATENOLOLGeneric (ANDA)
ANDA 076907 · ABLE
- 2004ATENOLOLGeneric (ANDA)
ANDA 074056 · TEVA
- 1999ATENOLOLGeneric (ANDA)
ANDA 073457 · MYLAN
- 1998ATENOLOLGeneric (ANDA)
ANDA 074126 · 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.
