Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Haldol (haloperidol) Tablets, Concentrate, Injection, and Haldol (haloperidol) Decanoate Injection, The R.W. Johnson Pharmaceutical Research Institute NDA 15-921/S76, 15-922/S66, 15-923/S72 & 18-701/S46 Haloperidol Injection, 5 mg/mL, Gensia Sicor ANDA 76-035 8/29/01 4/16/03 Haloperidol Injection, 5 mg/mL, Bedford ANDA 75-858 6/18/01 6/26/01 Haloperidol Injection, 5 mg (base)/mL, American Pharmaceutical Partners, ANDA 75-689 3/9/01 3/30/01 Haloperidol Decanoate Injection, 50 mg (base)/mL & 100 mg (base)/mL (Multi-Dose Vials)., Apotex Corp. ANDA 75-440 2/28/00 2/29/00 Haloperidol Decanoate Injection, 50 mg (base)/mL & 100 mg (base)/mL (Single & Multi-Dose Vials). Gensia Sicor ANDA 75-393 5/11/99 5/18/99 7/11/01 Haloperidol Decanoate Injection, 100 mg (base)/mL, Bedford ANDA 75-305 9/28/98 9/29/98 9/25/02 Haloperidol Decanoate Injection, 50 mg (base)/mL and 100 mg (base)/mL, (packaged in 1 mL ampules and 5 mL multiple-dose vials), King ANDA 75-176 HALOPERIDOL Tablet; 0.5MG HALOPERIDOL Geneva 071210 HALOPERIDOL Tablet; 10MG HALOPERIDOL Geneva 071207 HALOPERIDOL Tablet; 1MG HALOPERIDOL Geneva 071211 HALOPERIDOL Tablet; 20MG HALOPERIDOL Geneva 071208 HALOPERIDOL Tablet; 2MG HALOPERIDOL Geneva 071209 HALOPERIDOL Tablet; 5MG HALOPERIDOL Geneva 070276 HALOPERIDOL Tablet; 0.5MG HALOPERIDOL Mylan 070277 HALOPERIDOL Tablet; 1MG HALOPERIDOL Mylan 070278 HALOPERIDOL Tablet; 2MG HALOPERIDOL Mylan 070279 HALOPERIDOL Tablet; 5MG HALOPERIDOL Mylan 071233 HALOPERIDOL Tablet; 0.5MG HALOPERIDOL Par 071237 HALOPERIDOL Tablet; 10MG HALOPERIDOL Par 071234 HALOPERIDOL Tablet; 1MG HALOPERIDOL Par 071235 HALOPERIDOL Tablet; 2MG HALOPERIDOL Par 071236 HALOPERIDOL Tablet; 5MG HALOPERIDOL Par 070981 HALOPERIDOL Tablet; 0.5MG HALOPERIDOL Watson 070983 HALOPERIDOL Tablet; 2MG HALOPERIDOL Watson 070984 HALOPERIDOL Tablet; 5MG HALOPERIDOL Watson 074893 AO HALOPERIDOL DECANOATE Injection 100MG BASE/ML HALOPERIDOL DECANOATE AM PARTNERS 074893 AO HALOPERIDOL DECANOATE Injection 50MG BASE/ML HALOPERIDOL DECANOATE AM PARTNERS 075440 AO HALOPERIDOL DECANOATE Injection 100MG BASE/ML HALOPERIDOL DECANOATE Apotex 075440 AO HALOPERIDOL DECANOATE Injection 50MG BASE/ML HALOPERIDOL DECANOATE Apotex 075305 AO HALOPERIDOL DECANOATE Injection 100MG BASE/ML HALOPERIDOL DECANOATE Bedford 074811 AO HALOPERIDOL DECANOATE Injection 50MG BASE/ML HALOPERIDOL DECANOATE Bedford 075393 AO HALOPERIDOL DECANOATE Injection 100MG BASE/ML HALOPERIDOL DECANOATE Gensia Sicor 075393 AO HALOPERIDOL DECANOATE Injection 50MG BASE/ML HALOPERIDOL DECANOATE Gensia Sicor 018701 AO HALOPERIDOL DECANOATE Injection 100MG BASE/ML HALDOL ORTHO MCNEIL 018701 AO HALOPERIDOL DECANOATE Injection 50MG BASE/ML HALDOL ORTHO MCNEIL 071617 HALOPERIDOL LACTATE Concentrate; 2MG BASE/ML HALOPERIDOL Copley 073037 HALOPERIDOL LACTATE Concentrate; 2MG BASE/ML HALOPERIDOL ASSOC 073364 HALOPERIDOL LACTATE Concentrate; 2MG BASE/ML HALOPERIDOL SILARX 071015 HALOPERIDOL LACTATE Concentrate; 2MG BASE/ML HALOPERIDOL Teva 075689 HALOPERIDOL LACTATE Injection 5MG BASE/ML HALOPERIDOL AM PARTNERS 075858 HALOPERIDOL LACTATE Injection 5MG BASE/ML HALOPERIDOL Bedford 076035 HALOPERIDOL LACTATE Injection 5MG BASE/ML HALOPERIDOL Gensia Sicor 015923 HALOPERIDOL LACTATE Injection 5MG BASE/ML HALDOL ORTHO MCNEIL 070714 HALOPERIDOL LACTATE Injection 5MG BASE/ML HALOPERIDOL STERIS 074536 HALOPERIDOL LACTATE Solution; 1MG BASE/ML HALOPERIDOL LACTATE UDL Haloperidol Injection, Apotex Corp., Approval Haloperidol Injection, Apotex Corp., Approval Haloperidol Injection, Apotex Corp., Approval | Haloperidol Injection, Sabex 2002 Inc., Approval | Haloperidol Decanoate Injection, Apotex Corp., Supplement | Haloperidol Deconoate Injection, Sabex 2002, Approval | Haldol (haloperidol) Injection, Johnson & Johnson, Labeling Revision | Haldol Decanoate (haloperidol) IM Injection, Johnson & Johnson, Labeling Revision | Haldol (haloperidol) Injection, Ortho McNeil Pharma, Labeling Revision | Haldol (haloperidol) Decanoate Injection, Ortho McNeil Pharma, Labeling Revision | Haloperidol Tablets, Zydus Pharma, Approval | Haldol (haloperidol decanoate) Injection, Ortho McNeil Pharmaceutical, Labeling Revision | Haldol (haloperidol lactate) Injection, Ortho McNeil Pharmaceutical, Labeling Revision | Haldol (haloperidol decanoate) Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision | Haldol (haloperidol lactate) Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision | Haloperidol (haloperidol lactate) Injection, APP Pharmaceuticals, LLC, Labeling | Haloperidol Decanoate Injection, APP Pharmaceuticals, LLC, Labeling ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com