FDA Orange Book · active-ingredient family
Haloperidol
Haloperidol is approved as 2 brand and 65 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:HALDOL · NDA 015921
2
Brand (NDA)
65
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HALDOLRLD×6 | ORTHO MCNEIL | NDA 015921 | — | Approved Prior to Jan 1, 1982 | |
| HALDOL SOLUTAB | ORTHO MCNEIL PHARM | NDA 017079 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (65)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HALOPERIDOL×5 | ALEMBIC | ANDA 214470 | AB | Jun 04, 2026 | |
| HALOPERIDOL×6 | AIPING PHARM INC | ANDA 071130 | AB | Apr 08, 2026 | |
| HALOPERIDOL×6 | CREEKWOOD PHARMS | ANDA 218162 | AB | Dec 18, 2025 | |
| HALOPERIDOL×6 | AUROBINDO PHARMA LTD | ANDA 218789 | AB | Apr 19, 2024 | |
| HALOPERIDOL×6 | MANKIND PHARMA | ANDA 216918 | AB | Apr 11, 2024 | |
| HALOPERIDOL×6 | ZYDUS PHARMS USA | ANDA 077580 | AB | Jan 17, 2023 | |
| HALOPERIDOL×6 | MSN | ANDA 216004 | AB | Nov 18, 2022 | |
| HALOPERIDOL×6 | ACTAVIS GROUP | ANDA 200854 | — | Jul 01, 2022 | |
| HALOPERIDOL×6 | APPCO | ANDA 211061 | AB | Jan 08, 2020 | |
| HALOPERIDOL | WATSON LABS | ANDA 072113 | — | Aug 27, 1991 | |
| HALOPERIDOL | WATSON LABS | ANDA 072353 | — | Aug 27, 1991 | |
| HALOPERIDOL | LEDERLE | ANDA 072727 | — | Sep 19, 1989 | |
| HALOPERIDOL | LEDERLE | ANDA 072728 | — | Sep 19, 1989 | |
| HALOPERIDOL | LEDERLE | ANDA 072729 | — | Sep 19, 1989 | |
| HALOPERIDOL | LEDERLE | ANDA 072730 | — | Sep 19, 1989 | |
| HALOPERIDOL | LEDERLE | ANDA 072731 | — | Sep 19, 1989 | |
| HALOPERIDOL | LEDERLE | ANDA 072732 | — | Sep 19, 1989 | |
| HALOPERIDOL | WATSON LABS | ANDA 071571 | — | Jun 03, 1988 | |
| HALOPERIDOL | WATSON LABS | ANDA 071572 | — | Jun 03, 1988 | |
| HALOPERIDOL | WATSON LABS | ANDA 071573 | — | Jun 03, 1988 | |
| HALOPERIDOL | WATSON LABS | ANDA 071374 | — | Jun 03, 1988 | |
| HALOPERIDOL | WATSON LABS | ANDA 071375 | — | Jun 03, 1988 | |
| HALOPERIDOL | WATSON LABS | ANDA 071376 | — | Jun 03, 1988 | |
| HALOPERIDOL | CHARTWELL RX | ANDA 071210 | AB | Mar 11, 1988 | |
| HALOPERIDOL | CHARTWELL RX | ANDA 071211 | AB | Mar 11, 1988 | |
| HALOPERIDOL | ROYCE LABS | ANDA 071722 | — | Dec 24, 1987 | |
| HALOPERIDOL | ROYCE LABS | ANDA 071723 | — | Dec 24, 1987 | |
| HALOPERIDOL | ROYCE LABS | ANDA 071724 | — | Dec 24, 1987 | |
| HALOPERIDOL | ROYCE LABS | ANDA 071725 | — | Dec 24, 1987 | |
| HALOPERIDOL | ROYCE LABS | ANDA 072121 | — | Dec 24, 1987 | |
| HALOPERIDOL | ROYCE LABS | ANDA 072122 | — | Dec 24, 1987 | |
| HALOPERIDOL | PUREPAC PHARM | ANDA 071075 | — | Aug 04, 1987 | |
| HALOPERIDOL | PUREPAC PHARM | ANDA 071076 | — | Aug 04, 1987 | |
| HALOPERIDOL | PAR PHARM | ANDA 071328 | — | Jul 20, 1987 | |
| HALOPERIDOL | DURAMED PHARMS BARR | ANDA 071220 | — | Jul 07, 1987 | |
| HALOPERIDOL | DURAMED PHARMS BARR | ANDA 071221 | — | Jul 07, 1987 | |
| HALOPERIDOL | AIPING PHARM INC | ANDA 071133 | — | May 12, 1987 | |
| HALOPERIDOL | WATSON LABS | ANDA 070981 | — | Mar 06, 1987 | |
| HALOPERIDOL | WATSON LABS | ANDA 070982 | — | Mar 06, 1987 | |
| HALOPERIDOL | WATSON LABS | ANDA 070983 | — | Mar 06, 1987 | |
| HALOPERIDOL | WATSON LABS | ANDA 070984 | — | Mar 06, 1987 | |
| HALOPERIDOL | AIPING PHARM INC | ANDA 071128 | — | Feb 17, 1987 | |
| HALOPERIDOL | AIPING PHARM INC | ANDA 071129 | — | Feb 17, 1987 | |
| HALOPERIDOL | QUANTUM PHARMICS | ANDA 071255 | — | Feb 17, 1987 | |
| HALOPERIDOL | QUANTUM PHARMICS | ANDA 071269 | — | Feb 17, 1987 | |
| HALOPERIDOL | QUANTUM PHARMICS | ANDA 071256 | — | Feb 17, 1987 | |
| HALOPERIDOL | QUANTUM PHARMICS | ANDA 071257 | — | Feb 17, 1987 | |
| HALOPERIDOL×6 | INNOGENIX | ANDA 071173 | AB | Jan 02, 1987 | |
| HALOPERIDOL | DURAMED PHARMS BARR | ANDA 071216 | — | Dec 04, 1986 | |
| HALOPERIDOL | DURAMED PHARMS BARR | ANDA 071217 | — | Dec 04, 1986 | |
| HALOPERIDOL | DURAMED PHARMS BARR | ANDA 071218 | — | Dec 04, 1986 | |
| HALOPERIDOL | DURAMED PHARMS BARR | ANDA 071219 | — | Dec 04, 1986 | |
| HALOPERIDOL×4 | CHARTWELL RX | ANDA 071209 | AB | Nov 17, 1986 | |
| HALOPERIDOL | PUREPAC PHARM | ANDA 071071 | — | Nov 03, 1986 | |
| HALOPERIDOL | PUREPAC PHARM | ANDA 071072 | — | Nov 03, 1986 | |
| HALOPERIDOL | PUREPAC PHARM | ANDA 071073 | — | Nov 03, 1986 | |
| HALOPERIDOL | PUREPAC PHARM | ANDA 071074 | — | Nov 03, 1986 | |
| HALOPERIDOL×5 | STRIDES PHARMA INTL | ANDA 071235 | — | Nov 03, 1986 | |
| HALOPERIDOL | SCS | ANDA 070725 | — | Sep 24, 1986 | |
| HALOPERIDOL×6 | MYLAN | ANDA 070278 | AB | Jun 10, 1986 | |
| HALOPERIDOL | SCS | ANDA 070720 | — | Jun 10, 1986 | |
| HALOPERIDOL | SCS | ANDA 070721 | — | Jun 10, 1986 | |
| HALOPERIDOL | SCS | ANDA 070722 | — | Jun 10, 1986 | |
| HALOPERIDOL | SCS | ANDA 070723 | — | Jun 10, 1986 | |
| HALOPERIDOL | SCS | ANDA 070724 | — | Jun 10, 1986 |
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.
Haloperidol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
