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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, 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 | Haldol (haloperidol decanoate) Injection, Johnson & Johnson Pharmaceutical R & D, L.L.C., Labeling Revision | Haldol (haloperidol lactate) Injection, Johnson & Johnson Pharmaceutical R & D, L.L.C., Labeling Revision | Haldol (haloperidol decanoate) Injection, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision | Haldol (haloperidol lactate) Injection, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision | Haldol (haloperidol lactate) Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, 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 | Haldol (haloperidol deconate) IM Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision | Haloperidol Injection, Sagent Pharmaceuticals, Inc., Approval
  
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