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