FDA Approval Activities for this Drug…

Phenergan (promethaszine HCl) Syrup and Fortis, Wyeth-Ayerst Research NDA 8-381/S-026 and S-027 Pherengan (promethazine HCl) Tablets, Wyeth-Ayerst NDA 7-935/S-025, S-026, & S-028 12/26/02 1/29/03 Pherengan (promethazine HCl) Suppositories, 50 mg., Wyeth-Ayerst NDA 11-689/S-016, S-018, S-019, & S-020 12/26/02 1/29/03 Pherengan (promethazine HCl) Suppositories, 12.5 mg and 25 mg., Wyeth-Ayerst NDA 10-926/S-017, S-020, S-021, and S-022 Promethazine Hydrochloride Injection USP, 25 mg/mL, PharmaForce, ANDA 40-515 3/19/03 Promethazine Hydrochloride Injection USP, 25 mg/mL, PharmaForce, ANDA 40-471 11/21/02 Promethazine Hydrochloride Injection USP, 25 mg/mL and 50 mg/mL, Gensia Sicor ANDA 40-454 8/22/02 4/9/03 Promethazine Hydrochloride Injection USP, 25 mg/mL and 50 mg/mL (Carpuject), Abbott ANDA 40-372 6/8/00 6/9/00 8/4/03 Promethazine Hydrochloride Suppositories USP, 12.5 & 25 mg, Able, ANDA 40-504 4/11/03 Promethazine Hydrochloride Suppositories USP, 12.5 & 25 mg, Clay-Park Labs ANDA 40-500 6/30/03 Promethazine Hydrochloride Suppositories USP, 12.5 & 25 mg, Paddock ANDA 40-479 6/24/03 Promethazine Hydrochloride Suppositories USP, 50 mg, Able, ANDA 40-449 2/27/03 Promethazine Hydrochloride Suppositories USP, 25 mg, G & W, ANDA 40-028 2/5/02 Promethazine Hydrochloride Syrup USP, 6.25 mg/5 mL, Hi-Tech Pharmacal ANDA 40-026 CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE Syrup; 10MG/5ML;5MG/5ML;6.25MG/5ML PROMETH VC W/ CODEINE ALPHARMA 088896 CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE Syrup; 10MG/5ML;5MG/5ML;6.25MG/5ML PROMETHAZINE VC W/ CODEINE Morton Grove 088763 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE Syrup; 10MG/5ML;6.25MG/5ML PROMETH W/ CODEINE ALPHARMA 040151 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE Syrup; 10MG/5ML;6.25MG/5ML PROMETHAZINE HCL AND CODEINE PHOSPHATE HI TECH 088875 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE Syrup; 10MG/5ML;6.25MG/5ML PROMETHAZINE W/ CODEINE Morton Grove 089647 CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE Syrup; 10MG/5ML;6.25MG/5ML PROMETHAZINE HCL AND CODEINE PHOSPHATE ASSOC 088762 DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE Syrup; 15MG/5ML;6.25MG/5ML PROMETH W/ DEXTROMETHORPHAN ALPHARMA 040027 DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE Syrup; 15MG/5ML;6.25MG/5ML PROMETHAZINE HCL AND DEXTROMETHORPHAN HYDROBROMIDE HI TECH 088864 DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE Syrup; 15MG/5ML;6.25MG/5ML PROMETHAZINE W/ DEXTROMETHORPHAN Morton Grove 088761 PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE Syrup; 5MG/5ML;6.25MG/5ML PROMETH VC PLAIN ALPHARMA 088897 PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE Syrup; 5MG/5ML;6.25MG/5ML PROMETHAZINE VC PLAIN Morton Grove 040372 PROMETHAZINE HYDROCHLORIDE Injection 25MG/ML PROMETHAZINE HCL Abbott 040372 PROMETHAZINE HYDROCHLORIDE Injection 50MG/ML PROMETHAZINE HCL Abbott 083838 PROMETHAZINE HYDROCHLORIDE Injection 50MG/ML PROMETHAZINE HCL Abbott 083312 PROMETHAZINE HYDROCHLORIDE Injection 25MG/ML PROMETHAZINE HCL Baxter 083312 PROMETHAZINE HYDROCHLORIDE Injection 50MG/ML PROMETHAZINE HCL Baxter 040454 PROMETHAZINE HYDROCHLORIDE Injection 25MG/ML PROMETHAZINE HCL Gensia Sicor 040454 PROMETHAZINE HYDROCHLORIDE Injection 50MG/ML PROMETHAZINE HCL Gensia Sicor 040471 PROMETHAZINE HYDROCHLORIDE Injection 25MG/ML PROMETHAZINE HCL Pharmaforce 040515 PROMETHAZINE HYDROCHLORIDE Injection 25MG/ML PROMETHAZINE HCL Pharmaforce 084591 PROMETHAZINE HYDROCHLORIDE Injection 25MG/ML PROMETHAZINE HCL STERIS 080629 PROMETHAZINE HYDROCHLORIDE Injection 50MG/ML PROMETHAZINE HCL STERIS 040504 PROMETHAZINE HYDROCHLORIDE Suppository; Rectal 12.5MG PROMETHAZINE HCL Able 040504 PROMETHAZINE HYDROCHLORIDE Suppository; Rectal 25MG PROMETHAZINE HCL Able 040449 PROMETHAZINE HYDROCHLORIDE Suppository; Rectal 50MG PROMETHAZINE HCL Able 040500 PROMETHAZINE HYDROCHLORIDE Suppository; Rectal 12.5MG PROMETHAZINE HCL Clay Park 040500 PROMETHAZINE HYDROCHLORIDE Suppository; Rectal 25MG PROMETHAZINE HCL Clay Park 040428 PROMETHAZINE HYDROCHLORIDE Suppository; Rectal 12.5MG PROMETHAZINE HCL G AND W 040428 PROMETHAZINE HYDROCHLORIDE Suppository; Rectal 25MG PROMETHAZINE HCL G AND W 087165 BR PROMETHAZINE HYDROCHLORIDE Suppository; Rectal 50MG PROMETHEGAN G AND W 040479 PROMETHAZINE HYDROCHLORIDE Suppository; Rectal 12.5MG PROMETHAZINE HCL Paddock 040479 PROMETHAZINE HYDROCHLORIDE Suppository; Rectal 25MG PROMETHAZINE HCL Paddock 084901 BR PROMETHAZINE HYDROCHLORIDE Suppository; Rectal 25MG PROMETHACON POLYMEDICA 010926 PROMETHAZINE HYDROCHLORIDE Suppository; Rectal 12.5MG PHENERGAN Wyeth INC 010926 PROMETHAZINE HYDROCHLORIDE Suppository; Rectal 25MG PHENERGAN Wyeth INC 011689 PROMETHAZINE HYDROCHLORIDE Suppository; Rectal 50MG PHENERGAN Wyeth INC 085953 PROMETHAZINE HYDROCHLORIDE Syrup; 6.25MG/5ML PROMETH PLAIN ALPHARMA 040026 PROMETHAZINE HYDROCHLORIDE Syrup; 6.25MG PROMETHAZINE HCL HI TECH 087953 PROMETHAZINE HYDROCHLORIDE Syrup; 6.25MG/5ML PROMETHAZINE PLAIN Morton Grove 086395 PROMETHAZINE HYDROCHLORIDE Syrup; 6.25MG/5ML PROMETHAZINE HCL WHITEWORTH TOWN PLSN 084234 BP PROMETHAZINE HYDROCHLORIDE Tablet; 25MG PROMETHAZINE HCL Geneva 084176 BP PROMETHAZINE HYDROCHLORIDE Tablet; 50MG PROMETHAZINE HCL Geneva 083426 BP PROMETHAZINE HYDROCHLORIDE Tablet; 25MG PROMETHAZINE HCL Watson 083711 BP PROMETHAZINE HYDROCHLORIDE Tablet; 50MG PROMETHAZINE HCL Watson 007935 PROMETHAZINE HYDROCHLORIDE Tablet; 12.5MG PHENERGAN Wyeth INC 007935 BP PROMETHAZINE HYDROCHLORIDE Tablet; 25MG PHENERGAN Wyeth INC 007935 BP PROMETHAZINE HYDROCHLORIDE Tablet; 50MG PHENERGAN Wyeth INC Phenergan w/dextromethorphan (promethazine HCl & dextromethorphan hydrobromide) Syrup, Wyeth Pharmaceuticals Promethazine Hydrochloride Injection USP, Bedford Laboratories Promethazine Hydrochloride Tablets USP, Able Laboratories, Approval | Phenergan (promethazine HCl) Suppositories, Wyeth Pharma, Labeling Revision | Phenergan (promethazine HCl) Suppositories, Wyeth Pharma, Labeling Revision | Phenergan (promethazine HCl) Suppositories, Wyeth Pharma, Labeling Revision

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