FDA Orange Book · active-ingredient family
Atenolol; chlorthalidone
Atenolol; chlorthalidone is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TENORETIC 100 · NDA 018760
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TENORETIC 100RLD×2 | TWI PHARMS | NDA 018760 | — | Jun 08, 1984 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ATENOLOL AND CHLORTHALIDONE×2 | NOVITIUM PHARMA | ANDA 215560 | AB | Oct 25, 2021 | |
| ATENOLOL AND CHLORTHALIDONE×2 | UNICHEM | ANDA 213302 | AB | Nov 25, 2020 | |
| ATENOLOL AND CHLORTHALIDONE×2 | ZYDUS PHARMS | ANDA 210028 | AB | Mar 08, 2019 | |
| ATENOLOL AND CHLORTHALIDONE×2 | NOSTRUM LABS | ANDA 074404 | — | May 14, 1998 | |
| ATENOLOL AND CHLORTHALIDONE×2 | PLIVA | ANDA 074107 | — | Sep 24, 1997 | |
| ATENOLOL AND CHLORTHALIDONE×2 | AUROBINDO PHARMA USA | ANDA 074203 | — | Oct 31, 1993 | |
| ATENOLOL AND CHLORTHALIDONE×2 | SUN PHARM INDUSTRIES | ANDA 073582 | — | Apr 29, 1993 | |
| ATENOLOL AND CHLORTHALIDONE×2 | WATSON LABS | ANDA 073665 | AB | Jul 02, 1992 | |
| ATENOLOL AND CHLORTHALIDONE×2 | AIPING PHARM INC | ANDA 072302 | AB | May 31, 1990 |
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; chlorthalidone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
