Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.