FDA Orange Book · active-ingredient family
Haloperidol decanoate
Haloperidol decanoate is approved as 1 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:HALDOL · NDA 018701
1
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HALDOLRLD×2 | JANSSEN PHARMS | NDA 018701 | — | Jan 14, 1986 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HALOPERIDOL DECANOATE×2 | CAPLIN | ANDA 219168 | AO | May 13, 2025 | |
| HALOPERIDOL DECANOATE×2 | MANKIND PHARMA | ANDA 216730 | AO | May 23, 2023 | |
| HALOPERIDOL DECANOATE×2 | MEITHEAL | ANDA 214507 | AO | Jul 26, 2021 | |
| HALOPERIDOL DECANOATE×2 | ZYDUS PHARMS | ANDA 211180 | AO | Oct 22, 2019 | |
| HALOPERIDOL DECANOATE×2 | SOMERSET THERAPS LLC | ANDA 209101 | AO | Jul 03, 2018 | |
| HALOPERIDOL DECANOATE×2 | GLAND | ANDA 205241 | AO | May 12, 2017 | |
| HALOPERIDOL DECANOATE×2 | SANDOZ | ANDA 076463 | — | Jun 24, 2005 | |
| HALOPERIDOL DECANOATE×2 | MYLAN LABS LTD | ANDA 075440 | AO | Feb 28, 2000 | |
| HALOPERIDOL DECANOATE×2 | HOSPIRA | ANDA 075176 | — | Feb 09, 2000 | |
| HALOPERIDOL DECANOATE×2 | TEVA PHARMS USA | ANDA 075393 | — | May 11, 1999 | |
| HALOPERIDOL DECANOATE | HIKMA | ANDA 075305 | AO | Sep 28, 1998 | |
| HALOPERIDOL DECANOATE | HIKMA | ANDA 074811 | — | Jan 30, 1998 | |
| HALOPERIDOL DECANOATE×2 | FRESENIUS KABI USA | ANDA 074893 | AO | Dec 19, 1997 |
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 decanoate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
