FDA Approval Activities for this Drug…

Bicillin CR and Bicillin CR 900/300 (Penicillin G Benzathine and Penicillin G Procaine Injectable Suspension, USP) and Bicillin LA (Penicillin G Benzathine Injectable Suspension), King NDA 50-138/S-222, 50-138/S-223, 50-141/S-218 & 50-141/S-219 4/29/02 5/2/02 Bicillin C-R and Bicillin C-R 900/300 Injection, Wyeth-Ayerst Research NDA 50-138/S-219 3/1/02 3/5/02 Bicillin L-A (penicillin G benzathine suspension) Injection, Wyeth-Ayerst Research NDA 50-141/S-215 Penicillin G Potassium Injection, USP, 1,000,000; 5,000,000; & 20,000,000 Units, Biochemie GmbH NDA 65-079 8/30/02 Penicillin G Potassium Injection, USP, in Galaxy Container Baxter Healthcare NDA 50-638/S-007 8/23/02 8/30/02 Penicillin G Sodium for Injection USP,Rx Biochemie GmbH ANDA 65-068 2/26/01 3/6/01 Penlac Nail Lacquer (ciclopirox) Topical Solution, 8%. Aventis NDA 21-022/S2 PENICILLIN G BENZATHINE Injection 300,000 UNITS/ML BICILLIN L-A KING 050141 BC PENICILLIN G BENZATHINE Injection 600,000 UNITS/ML BICILLIN L-A KING 060014 BC PENICILLIN G BENZATHINE Injection 600,000 UNITS/ML PERMAPEN PFIZER 050138 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE Injection 150,000 UNITS/ML;150,000 UNITS/ML BICILLIN C-R KING 050138 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE Injection 300,000 UNITS/ML;300,000 UNITS/ML BICILLIN C-R KING 050138 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE Injection 900,000 UNITS/2ML;300,000 UNITS/2ML BICILLIN C-R 900/300 KING 050638 PENICILLIN G POTASSIUM Injection 20,000 UNITS/ML PENICILLIN G POTASSIUM IN PLASTIC CONTAINER Baxter 050638 PENICILLIN G POTASSIUM Injection 40,000 UNITS/ML PENICILLIN G POTASSIUM IN PLASTIC CONTAINER Baxter 050638 PENICILLIN G POTASSIUM Injection 60,000 UNITS/ML PENICILLIN G POTASSIUM IN PLASTIC CONTAINER Baxter 065079 PENICILLIN G POTASSIUM Injection 1,000,000 UNITS/VIAL PENICILLIN G POTASSIUM Geneva 065079 PENICILLIN G POTASSIUM Injection 20,000,000 UNITS/VIAL PENICILLIN G POTASSIUM Geneva 065079 PENICILLIN G POTASSIUM Injection 5,000,000 UNITS/VIAL PENICILLIN G POTASSIUM Geneva 060657 PENICILLIN G POTASSIUM Injection 1,000,000 UNITS/VIAL PFIZERPEN PFIZER 060657 PENICILLIN G POTASSIUM Injection 20,000,000 UNITS/VIAL PFIZERPEN PFIZER 060074 PENICILLIN G POTASSIUM Injection 20,000,000 UNITS/VIAL PENICILLIN G POTASSIUM PFIZER 060657 PENICILLIN G POTASSIUM Injection 5,000,000 UNITS/VIAL PFIZERPEN PFIZER 060101 PENICILLIN G PROCAINE Injection 300,000 UNITS/ML WYCILLIN KING 060101 PENICILLIN G PROCAINE Injection 600,000 UNITS/ML WYCILLIN KING 065068 PENICILLIN G SODIUM Im-Iv 5,000,000 UNITS/VIAL PENICILLIN G SODIUM Biochemie 061410 PENICILLIN V POTASSIUM For Solution; 125MG BASE/5ML VEETIDS APOTHECON 061410 PENICILLIN V POTASSIUM For Solution; 250MG BASE/5ML VEETIDS APOTHECON 062981 PENICILLIN V POTASSIUM For Solution; 125MG BASE/5ML PENICILLIN V POTASSIUM CLONMEL 062981 PENICILLIN V POTASSIUM For Solution; 250MG BASE/5ML PENICILLIN V POTASSIUM CLONMEL 061529 PENICILLIN V POTASSIUM For Solution; 125MG BASE/5ML PENICILLIN V POTASSIUM CONSOLIDATED 061529 PENICILLIN V POTASSIUM For Solution; 250MG BASE/5ML PENICILLIN V POTASSIUM CONSOLIDATED 062270 PENICILLIN V POTASSIUM For Solution; 125MG BASE/5ML BEEPEN-VK GLAXOSMITHKLINE 062270 PENICILLIN V POTASSIUM For Solution; 250MG BASE/5ML BEEPEN-VK GLAXOSMITHKLINE 060456 PENICILLIN V POTASSIUM For Solution; 125MG BASE/5ML PENICILLIN-VK Teva 060456 PENICILLIN V POTASSIUM For Solution; 250MG BASE/5ML PENICILLIN-VK Teva 061411 PENICILLIN V POTASSIUM Tablet; 250MG BASE VEETIDS APOTHECON 061411 PENICILLIN V POTASSIUM Tablet; 500MG BASE VEETIDS APOTHECON 064071 PENICILLIN V POTASSIUM Tablet; 250MG BASE PENICILLIN V POTASSIUM Biochemie 064071 PENICILLIN V POTASSIUM Tablet; 500MG BASE PENICILLIN V POTASSIUM Biochemie 061150 PENICILLIN V POTASSIUM Tablet; 250MG BASE BETAPEN-VK BRISTOL 061150 PENICILLIN V POTASSIUM Tablet; 500MG BASE BETAPEN-VK BRISTOL 062936 PENICILLIN V POTASSIUM Tablet; 250MG BASE PENICILLIN V POTASSIUM CLONMEL 062935 PENICILLIN V POTASSIUM Tablet; 500MG BASE PENICILLIN V POTASSIUM CLONMEL 061528 PENICILLIN V POTASSIUM Tablet; 250MG BASE PENICILLIN V POTASSIUM CONSOLIDATED 061528 PENICILLIN V POTASSIUM Tablet; 500MG BASE PENICILLIN V POTASSIUM CONSOLIDATED 062273 PENICILLIN V POTASSIUM Tablet; 250MG BASE BEEPEN-VK GLAXOSMITHKLINE 062273 PENICILLIN V POTASSIUM Tablet; 500MG BASE BEEPEN-VK GLAXOSMITHKLINE 061651 PENICILLIN V POTASSIUM Tablet; 250MG BASE UTICILLIN VK PHARMACIA AND UPJOHN 060711 PENICILLIN V POTASSIUM Tablet; 250MG BASE PENICILLIN-VK Teva 060711 PENICILLIN V POTASSIUM Tablet; 500MG BASE PENICILLIN-VK Teva Penicillin G Potassium Injection, Baxter Healthcare Corporation | Bicillin C-R and Bicillin C-R 900/300 (Penicillin G Benzathine and Penicillin G Procaine) Injectable Suspension, King Pharma, Labeling Revision | Penicillin G Injection, Baxter Healthcare, Labeling Revision

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