FDA Orange Book · active-ingredient family
Haloperidol lactate
Haloperidol lactate is approved as 2 brand and 32 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:HALDOL · NDA 015922
2
Brand (NDA)
32
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · concentrate, injectable, solution
Generic (ANDA) products (32)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HALOPERIDOL | RUBICON RESEARCH | ANDA 218371 | AA | Jan 31, 2024 | |
| HALOPERIDOL | FRESENIUS KABI USA | ANDA 210356 | — | Jul 01, 2019 | |
| HALOPERIDOL | EPIC PHARMA LLC | ANDA 204849 | — | Sep 06, 2017 | |
| HALOPERIDOL | SAGENT PHARMS | ANDA 091637 | AP | Sep 02, 2011 | |
| HALOPERIDOL | SAGENT PHARMS | ANDA 200742 | AP | Sep 02, 2011 | |
| HALOPERIDOL | MYLAN LABS LTD | ANDA 078347 | AP | Sep 14, 2009 | |
| HALOPERIDOL | FOSUN PHARMA | ANDA 076464 | — | Sep 29, 2004 | |
| HALOPERIDOL | BAXTER HLTHCARE CORP | ANDA 076791 | — | Aug 25, 2004 | |
| HALOPERIDOL | BAXTER HLTHCARE CORP | ANDA 076828 | — | Aug 25, 2004 | |
| HALOPERIDOL | GLAND PHARMA LTD | ANDA 076774 | — | Aug 25, 2004 | |
| HALOPERIDOL | TEVA PHARMS USA | ANDA 076035 | — | Aug 29, 2001 | |
| HALOPERIDOL | HIKMA | ANDA 075858 | AP | Jun 18, 2001 | |
| HALOPERIDOL | FRESENIUS KABI USA | ANDA 075689 | AP | Mar 09, 2001 | |
| HALOPERIDOL LACTATE | ACTAVIS MID ATLANTIC | ANDA 074536 | — | Nov 02, 1995 | |
| HALOPERIDOL | LANNETT CO INC | ANDA 073364 | AA | Sep 28, 1993 | |
| HALOPERIDOL | PHARM ASSOC | ANDA 073037 | AA | Feb 26, 1993 | |
| HALOPERIDOL | MARSAM PHARMS LLC | ANDA 072516 | — | Feb 25, 1993 | |
| HALOPERIDOL | MARSAM PHARMS LLC | ANDA 072517 | — | Feb 25, 1993 | |
| HALOPERIDOL | TEVA PHARMS | ANDA 071617 | — | Dec 01, 1988 | |
| HALOPERIDOL | WATSON LABS | ANDA 070713 | — | May 17, 1988 | |
| HALOPERIDOL | WATSON LABS | ANDA 070714 | — | May 17, 1988 | |
| HALOPERIDOL | WATSON LABS | ANDA 070744 | — | May 17, 1988 | |
| HALOPERIDOL INTENSOL | HIKMA | ANDA 072045 | — | Apr 12, 1988 | |
| HALOPERIDOL | SMITH AND NEPHEW | ANDA 070802 | — | Dec 14, 1987 | |
| HALOPERIDOL | SOLOPAK | ANDA 070800 | — | Dec 14, 1987 | |
| HALOPERIDOL | SOLOPAK | ANDA 070801 | — | Dec 14, 1987 | |
| HALOPERIDOL | SOLOPAK | ANDA 070864 | — | Dec 14, 1987 | |
| HALOPERIDOL | TEVA | ANDA 071015 | — | Aug 25, 1987 | |
| HALOPERIDOL | ABRAXIS PHARM | ANDA 071187 | — | Jan 20, 1987 | |
| HALOPERIDOL | SCS | ANDA 070726 | — | Jun 10, 1986 | |
| HALOPERIDOL | ALPHARMA | ANDA 070318 | — | Apr 11, 1986 | |
| HALOPERIDOL | MORTON GROVE | ANDA 070710 | — | Mar 07, 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 lactate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
