FDA Orange Book · active-ingredient family
Atenolol
Atenolol is approved as 2 brand and 30 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TENORMIN · NDA 018240
2
Brand (NDA)
30
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TENORMINRLD×3 | TWI PHARMS | NDA 018240 | AB | Apr 09, 1990 | |
| TENORMINRLD | ASTRAZENECA | NDA 019058 | — | Sep 13, 1989 |
Generic (ANDA) products (30)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ATENOLOL×3 | UNICHEM | ANDA 213136 | AB | Nov 21, 2019 | |
| ATENOLOL×3 | NORTHSTAR HLTHCARE | ANDA 078254 | — | Sep 25, 2009 | |
| ATENOLOL×3 | AUROBINDO PHARMA | ANDA 078512 | AB | Oct 31, 2007 | |
| ATENOLOL×3 | SUN PHARM INDS INC | ANDA 078210 | — | Jul 10, 2007 | |
| ATENOLOL×3 | IPCA LABS LTD | ANDA 077877 | AB | Dec 27, 2006 | |
| ATENOLOL×3 | UNIQUE | ANDA 077443 | AB | Sep 13, 2006 | |
| ATENOLOL×3 | ZYDUS PHARMS USA | ANDA 076900 | AB | Jan 28, 2005 | |
| ATENOLOL×3 | ABLE | ANDA 076907 | — | Jul 30, 2004 | |
| ATENOLOL×3 | TEVA | ANDA 074056 | AB | Jul 19, 2004 | |
| ATENOLOL×3 | MYLAN | ANDA 073457 | AB | Apr 26, 1999 | |
| ATENOLOL×3 | MYLAN | ANDA 074126 | — | Aug 26, 1998 | |
| ATENOLOL | SUN PHARM INDUSTRIES | ANDA 074499 | — | Jul 30, 1997 | |
| ATENOLOL×3 | PLIVA | ANDA 074101 | — | Jul 17, 1997 | |
| ATENOLOL×2 | TEVA PHARMS | ANDA 074120 | — | Feb 24, 1995 | |
| ATENOLOL×2 | NOSTRUM LABS | ANDA 074127 | — | Feb 21, 1995 | |
| ATENOLOL×3 | CHARTWELL RX | ANDA 074265 | — | Feb 28, 1994 | |
| ATENOLOL | TEVA | ANDA 073315 | — | May 28, 1993 | |
| ATENOLOL | TEVA | ANDA 073316 | — | May 28, 1993 | |
| ATENOLOL | SUN PHARM INDUSTRIES | ANDA 073475 | — | Mar 30, 1993 | |
| ATENOLOL | SUN PHARM INDUSTRIES | ANDA 073476 | — | Mar 30, 1993 | |
| ATENOLOL×2 | SCS | ANDA 073676 | — | Oct 30, 1992 | |
| ATENOLOL×3 | AIPING PHARM INC | ANDA 072304 | AB | Jul 31, 1992 | |
| ATENOLOL×3 | PHARMOBEDIENT | ANDA 073026 | AB | May 01, 1992 | |
| ATENOLOL | NOVITIUM PHARMA | ANDA 074099 | — | Apr 28, 1992 | |
| ATENOLOL | APOTHECON | ANDA 073317 | — | Mar 20, 1992 | |
| ATENOLOL | APOTHECON | ANDA 073318 | — | Mar 20, 1992 | |
| ATENOLOL | WATSON LABS | ANDA 073352 | — | Dec 27, 1991 | |
| ATENOLOL | WATSON LABS TEVA | ANDA 073353 | — | Dec 27, 1991 | |
| ATENOLOL | NOVITIUM PHARMA | ANDA 073542 | — | Dec 19, 1991 | |
| ATENOLOL | NOVITIUM PHARMA | ANDA 073543 | — | Dec 19, 1991 |
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.
Atenolol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
