FDA Approval Activities for this Drug…

Orphenadrine Citrate Injection, 30 mg/mL, Bedford ANDA 40-463 3/4/03 Orphenadrine Citrate Extended-Release Tablets, 100 mg, Impax, ANDA 40-368 6/23/00 10/30/00 Orphenadrine Citrate Extended-Release Tablets, 100 mg, Approved 1/29/1999 Kiel , ANDA# 40-249 1/29/99 2/5/99 8/1/03 Orphenadrine Citrate Extended-release Tablets, 100 mg, Invamed ANDA 40-284 6/19/98 6/19/98 Orphenadrine Citrate Extended-release Tablets, 100 mg. Eon Labs Manufacturing, ANDA 40-327 2/15/00 2/17/00 Orphenadrine Citrate, Aspirin, & Caffeine Tablets,25 mg/385 mg, & 50 mg/770 mg/60 mg. Jerome Stevens ANDA 74-988 4/30/99 5/4/99 Orphengesic(Orphenadrine Citrate 25 mg, Aspirin 385 mg & Caffeine 30 mg) & Orphengesic Forte(Orphenadrine Citrate 50 mg, Aspirin 770 mg & Caffeine 60 mg). Par ANDA 75-141 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE Tablet; 385MG;30MG;25MG NORGESIC 3M 013416 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE Tablet; 770MG;60MG;50MG NORGESIC FORTE 3M 074654 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE Tablet; 385MG;30MG;25MG ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE Eon 074654 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE Tablet; 770MG;60MG;50MG ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE Eon 074817 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE Tablet; 385MG;30MG;25MG INVAGESIC Geneva TECH 074817 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE Tablet; 770MG;60MG;50MG INVAGESIC FORTE Geneva TECH 075141 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE Tablet; 385MG;30MG;25MG ORPHENGESIC Par 075141 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE Tablet; 770MG;60MG;50MG ORPHENGESIC FORTE Par 074988 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE Tablet; 385MG;30MG;25MG ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE STEVENS J 074988 ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE Tablet; 770MG;60MG;50MG ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE STEVENS J 013055 ORPHENADRINE CITRATE Injection 30MG/ML NORFLEX 3M 040463 ORPHENADRINE CITRATE Injection 30MG/ML ORPHENADRINE CITRATE Bedford 087062 ORPHENADRINE CITRATE Injection 30MG/ML ORPHENADRINE CITRATE STERIS 084779 ORPHENADRINE CITRATE Injection 30MG/ML ORPHENADRINE CITRATE STERIS 012157 ORPHENADRINE CITRATE Tablet, Extended Release; 100MG NORFLEX 3M 040327 ORPHENADRINE CITRATE Tablet, Extended Release; 100MG ORPHENADRINE CITRATE Eon 040284 ORPHENADRINE CITRATE Tablet, Extended Release; 100MG ORPHENADRINE CITRATE Geneva TECH 040368 ORPHENADRINE CITRATE Tablet, Extended Release; 100MG ORPHENADRINE CITRATE Impax 040249 ORPHENADRINE CITRATE Tablet, Extended Release; 100MG ORPHENADRINE CITRATE KIEL

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