FDA Orange Book · active-ingredient family
Chlorthalidone
Chlorthalidone is approved as 3 brand and 59 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:HEMICLOR · NDA 218647
3
Brand (NDA)
59
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HEMICLORRLD | PRM PHARMA | NDA 218647 | — | Mar 17, 2025 | |
| THALITONERLD×2 | CASPER PHARMA LLC | NDA 019574 | — | Dec 20, 1988 | |
| HYGROTONRLD×2 | SANOFI AVENTIS US | NDA 012283 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (59)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CHLORTHALIDONE×2 | IPCA LABS LTD | ANDA 209162 | AB | Nov 12, 2024 | |
| CHLORTHALIDONE×2 | ALEMBIC | ANDA 216262 | AB | Aug 26, 2022 | |
| CHLORTHALIDONE×2 | MANKIND PHARMA | ANDA 215587 | AB | Aug 04, 2022 | |
| CHLORTHALIDONE | PHARMOBEDIENT | ANDA 212878 | AB | Feb 24, 2022 | |
| CHLORTHALIDONE | PHARMOBEDIENT | ANDA 212875 | AB | Feb 24, 2022 | |
| CHLORTHALIDONE×2 | INVENTIA | ANDA 211320 | AB | Feb 09, 2022 | |
| CHLORTHALIDONE×2 | SUNNY | ANDA 209068 | — | Jan 25, 2022 | |
| CHLORTHALIDONE×2 | AJANTA PHARMA LTD | ANDA 214129 | AB | Nov 27, 2020 | |
| CHLORTHALIDONE×2 | ALKEM LABS LTD | ANDA 213412 | AB | Feb 11, 2020 | |
| CHLORTHALIDONE×2 | UNICHEM | ANDA 211627 | AB | Aug 06, 2019 | |
| CHLORTHALIDONE×2 | AMNEAL PHARMS CO | ANDA 207204 | AB | Jul 01, 2019 | |
| CHLORTHALIDONE×2 | ZYDUS PHARMS | ANDA 207813 | AB | May 10, 2019 | |
| CHLORTHALIDONE×2 | CHARTWELL RX | ANDA 211063 | AB | Feb 26, 2019 | |
| CHLORTHALIDONE×2 | APPCO | ANDA 210742 | AB | Oct 12, 2018 | |
| CHLORTHALIDONE×2 | UMEDICA | ANDA 207222 | AB | May 24, 2018 | |
| CHLORTHALIDONE×2 | INGENUS PHARMS LLC | ANDA 206904 | AB | Mar 30, 2017 | |
| CHLORTHALIDONE | MUTUAL PHARM | ANDA 089738 | — | Sep 19, 1988 | |
| CHLORTHALIDONE | MUTUAL PHARM | ANDA 089739 | — | Sep 19, 1988 | |
| CHLORTHALIDONE | PIONEER PHARMS | ANDA 089591 | — | Jul 21, 1988 | |
| CHLORTHALIDONE | USL PHARMA | ANDA 089051 | — | Jun 01, 1987 | |
| CHLORTHALIDONE | USL PHARMA | ANDA 089052 | — | Jun 01, 1987 | |
| CHLORTHALIDONE×2 | SUN PHARM INDUSTRIES | ANDA 089286 | AB | Jul 21, 1986 | |
| CHLORTHALIDONE | PUREPAC PHARM | ANDA 088139 | — | Jul 16, 1986 | |
| CHLORTHALIDONE | BARR LABS INC | ANDA 088902 | — | Sep 19, 1985 | |
| CHLORTHALIDONE | BARR LABS INC | ANDA 088903 | — | Sep 19, 1985 | |
| CHLORTHALIDONE | COSETTE PHARMS NC | ANDA 088651 | — | May 30, 1985 | |
| CHLORTHALIDONE | IVAX PHARMS | ANDA 087947 | — | Feb 27, 1984 | |
| CHLORTHALIDONE | ANI PHARMS | ANDA 088164 | — | Jan 09, 1984 | |
| CHLORTHALIDONE | PUREPAC PHARM | ANDA 088140 | — | Aug 11, 1983 | |
| CHLORTHALIDONE | VANGARD | ANDA 088073 | — | Mar 25, 1983 | |
| CHLORTHALIDONE | SUPERPHARM | ANDA 087473 | — | Feb 09, 1983 | |
| CHLORTHALIDONE | SUPERPHARM | ANDA 087247 | — | Feb 09, 1983 | |
| CHLORTHALIDONE | WARNER CHILCOTT | ANDA 087516 | — | Feb 09, 1983 | |
| CHLORTHALIDONE | WARNER CHILCOTT | ANDA 087515 | — | Jan 24, 1983 | |
| THALITONE | MONARCH PHARMS | ANDA 088051 | — | Nov 12, 1982 | |
| CHLORTHALIDONE | ASCOT | ANDA 087698 | — | Oct 20, 1982 | |
| CHLORTHALIDONE | ASCOT | ANDA 087699 | — | Oct 20, 1982 | |
| CHLORTHALIDONE | VANGARD | ANDA 088012 | — | Jul 14, 1982 | |
| CHLORTHALIDONE | ABBOTT | ANDA 087364 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | ABBOTT | ANDA 087384 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE×2 | AIPING PHARM INC | ANDA 087381 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | ANI PHARMS | ANDA 087296 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | ANI PHARMS | ANDA 087706 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | ANI PHARMS | ANDA 087689 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | DAVA PHARMS INC | ANDA 087451 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | DAVA PHARMS INC | ANDA 087450 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | IVAX PHARMS | ANDA 087555 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | IVAX PHARMS | ANDA 087176 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | KV PHARM | ANDA 087311 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | KV PHARM | ANDA 087312 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | MUTUAL PHARM | ANDA 087292 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | MUTUAL PHARM | ANDA 087293 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONERLD×2 | MYLAN | ANDA 086831 | AB | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | SANDOZ | ANDA 087118 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | WATSON LABS | ANDA 087050 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | WATSON LABS | ANDA 087100 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | WATSON LABS | ANDA 087029 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | WATSON LABS | ANDA 087082 | — | Approved Prior to Jan 1, 1982 | |
| CHLORTHALIDONE | WATSON LABS | ANDA 087521 | — | Approved Prior to Jan 1, 1982 |
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.
Chlorthalidone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
