|
|
|
 |
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 | Promethazine Hydrochloride Tablets, Zydus Pharma, Approval | Promethazine Hydrochloride and Dextromethorphan Hydrobromide Syrup, Vintage Pharma, Approval | Promethazine Hydrochloride Syrup, Vintage Pharma, Approval | Promethazine Hydrochloride Tablets, Vintage Pharma, Approval | Promethazine Hydrochloride Tablets, KVK-Tech, Approval | Promethazine Hydrochloride Suppositories, Taro Pharma, Approval | Promethazine Hydrochloride Injection, Sandoz, Inc., Approval | Promethazine Hydrochloride, Phenylephrine Hydrochloride Oral Solution, Vintage Pharma, Approval | Promethazine Hydrochloride, Phenylephrine Hydrochloride & Codeine Phosphate Oral Solution, Vintage Pharma, Approval | Promethazine HCl Syrup (Promethazine Hydrochloride) Oral Solution, Taro Pharma, Approval | Promethazine Hydrochloride Tablets, KVK-Tech Inc., New Strength | Promethazine Hydrochloride Tablets, Impax Labs, Approval | Promethazine Hydrochloride Tablets, Actavis Totowa, Approval | Phenergan Fortis (promethazine hydrochloride) Syrup, ANI Pharma, Manufacturing Change or Addition | Phenergan Plain (promethazine hydrochloride) Syrup, ANI Pharma, Manufacturing Change or Addition | Phenergan with Dextromethorphan (promethazine hydrochloride, dextromethorphan hydrobromide) Syrup, ANI Pharma, Manufacturing Change or Addition | Promethazine Hydrochloride Injection, Hikma Farmaceutica, Approval | Promethazine Hydrochloride Tablets, Impax Laboratories, Inc., Approval | Promethazine Hydrochloride Injection, Wockhardt USA, Inc., Approval | Promethazine Hydrochloride Injection, Wockhardt Ltd., Approval | Promethazine Hydrochloride Syrup, ANI Pharmaceuticals, Inc., Labeling Revision | Promethazine Hydrochloride Plain (promethazine hydrochloride) Oral Solution, ANI Pharmaceuticals, Inc., Labeling Revision | Phenergan w/Codeine (codeine phosphate and promethazine hydrochloride) Syrup, , ANI Pharmaceuticals, Inc., Labeling Revision | Promethazine Hydrochloride Tablets, Sun Pharmaceutical Industries, Inc., Approal | Promethazine Hydrochloride Syrup , SuN Pharmaceutical Industries, Inc., Approval | Promethazine Hydrochloride and Phenylephrine Hydrochloride Syrup, Amneal Pharmaceuticals, Approval | Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution, ANI Pharmaceuticals, Inc., Labeling Revision | Promethazine Hydrochloride Syrup, Amneal Pharmaceuticals, Approval | Promethazine Hydrochloride and Codeine Phosphate Syrup, SUN Pharmaceutical, Approval | Promethazine Hydrochloride Tablets, Amneal Pharmaceuticals of NY LLC, Approval | Promethazine Hydrochloride and Dextromethorphan Hydrobromide Syrup, Amneal Pharmaceuticals, Approval | Promethazine Hydrochloride Tablets, Mylan Phramaceuticals, Inc., Approval
  
|