FDA Approval Activities for this Drug…

Compazine (prochlorperazine maleate) Tablets, Spansule Capsules, Ampuls/Vials, Suppositories, and Syrup. SmithKline Beecham NDA 21-019/S001, 11-188/S049, 11-127/S061, 11-000/S084, 10-742/S065, & 10-571/S095 4/3/01 5/2/01 Compazine Spansule Capsules, Smithkline Beecham NDA N21-019 10/6/99 2/7/00 Compazine Indication: same as original NDA #11-000 1) control of severe nausea and vomiting 2) management of psychotic disorders 3) short-term treatment of generalized non-psychotic anxiety Compro (Prochlorperazine) Suppositories USP, 25 mg, Paddock, ANDA 40-246 Prochlorperazine Edisylate Injection, 5 mg, Gensia Sicor ANDA 40-505 5/30/03 Prochlorperazine Maleate Tablets USP, 5 mg (base) & 10 mg (base) Zenith Goldline ANDA 40-162 1/20/98 3/16/99 3/16/99 3/16/99 Prochlorperazine Maleate Tablets USP, 5 mg (base) & 10 mg (base) Trigen , ANDA 40-268 PROCHLORPERAZINE Suppository; Rectal 2.5MG PROCHLORPERAZINE Able 040407 PROCHLORPERAZINE Suppository; Rectal 25MG PROCHLORPERAZINE Able 040407 PROCHLORPERAZINE Suppository; Rectal 5MG PROCHLORPERAZINE Able 040058 PROCHLORPERAZINE Suppository; Rectal 25MG PROCHLORPERAZINE G AND W 011127 PROCHLORPERAZINE Suppository; Rectal 2.5MG COMPAZINE GLAXOSMITHKLINE 011127 PROCHLORPERAZINE Suppository; Rectal 25MG COMPAZINE GLAXOSMITHKLINE 011127 PROCHLORPERAZINE Suppository; Rectal 5MG COMPAZINE GLAXOSMITHKLINE 040246 PROCHLORPERAZINE Suppository; Rectal 25MG COMPRO Paddock 089703 PROCHLORPERAZINE EDISYLATE Injection 5MG BASE/ML PROCHLORPERAZINE EDISYLATE Abbott 087759 PROCHLORPERAZINE EDISYLATE Injection 5MG BASE/ML PROCHLORPERAZINE Baxter 089903 PROCHLORPERAZINE EDISYLATE Injection 5MG BASE/ML PROCHLORPERAZINE EDISYLATE ELKINS SINN 040505 PROCHLORPERAZINE EDISYLATE Injection 5MG BASE/ML PROCHLORPERAZINE EDISYLATE Gensia Sicor 010742 PROCHLORPERAZINE EDISYLATE Injection 5MG BASE/ML COMPAZINE GLAXOSMITHKLINE 089530 PROCHLORPERAZINE EDISYLATE Injection 5MG BASE/ML PROCHLORPERAZINE EDISYLATE STERIS 011188 PROCHLORPERAZINE EDISYLATE Syrup; 5MG BASE/5ML COMPAZINE GLAXOSMITHKLINE 021019 PROCHLORPERAZINE MALEATE Capsule, Extended Release; 10MG BASE COMPAZINE GLAXOSMITHKLINE 021019 PROCHLORPERAZINE MALEATE Capsule, Extended Release; 15MG BASE COMPAZINE GLAXOSMITHKLINE 040120 PROCHLORPERAZINE MALEATE Tablet; 10MG BASE PROCHLORPERAZINE MALEATE Copley 040120 PROCHLORPERAZINE MALEATE Tablet; 5MG BASE PROCHLORPERAZINE MALEATE Copley 040207 PROCHLORPERAZINE MALEATE Tablet; 10MG BASE PROCHLORPERAZINE MALEATE DURAMED Barr 040207 PROCHLORPERAZINE MALEATE Tablet; 5MG BASE PROCHLORPERAZINE MALEATE DURAMED Barr 040101 PROCHLORPERAZINE MALEATE Tablet; 10MG BASE PROCHLORPERAZINE MALEATE Geneva TECH 040101 PROCHLORPERAZINE MALEATE Tablet; 25MG BASE PROCHLORPERAZINE MALEATE Geneva TECH 040101 PROCHLORPERAZINE MALEATE Tablet; 5MG BASE PROCHLORPERAZINE MALEATE Geneva TECH 010571 PROCHLORPERAZINE MALEATE Tablet; 10MG BASE COMPAZINE GLAXOSMITHKLINE 010571 PROCHLORPERAZINE MALEATE Tablet; 25MG BASE COMPAZINE GLAXOSMITHKLINE 010571 PROCHLORPERAZINE MALEATE Tablet; 5MG BASE COMPAZINE GLAXOSMITHKLINE 040162 PROCHLORPERAZINE MALEATE Tablet; 10MG BASE PROCHLORPERAZINE MALEATE Ivax 040162 PROCHLORPERAZINE MALEATE Tablet; 5MG BASE PROCHLORPERAZINE MALEATE Ivax 040185 PROCHLORPERAZINE MALEATE Tablet; 10MG BASE PROCHLORPERAZINE MALEATE Mylan 040185 PROCHLORPERAZINE MALEATE Tablet; 5MG BASE PROCHLORPERAZINE MALEATE Mylan 040268 PROCHLORPERAZINE MALEATE Tablet; 10MG BASE PROCHLORPERAZINE MALEATE TRIGEN 040268 PROCHLORPERAZINE MALEATE Tablet; 5MG BASE PROCHLORPERAZINE MALEATE TRIGEN

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