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FDA Approval Activities for this Drug…
ATNAA (Atropine/Pralidoxime) Autoinjector, U.S. Army NDA 21-175 AtroPen (atropine) Injection Meridian Medical Technologies NDA 17-106/S28 6/19/03 6/25/03 6/25/03 Atropine Sulfate Injection, USP, 0.1 mg/mL & 0.05 mg/mL, Abbot NDA 21-146 7/9/01 10/17/01 10/17/01 10/17/01 Atropine Indications: When excessive (or sometimes normal) muscarinic effects are judged to be life threatening or are producing symptoms severe enough to call for temporary, reversible muscarinic blockade. ATROPINE Injection 0.5MG SULFATE/0.7ML ATROPEN MERIDIAN MEDCL TECHN 017106 ATROPINE Injection 1MG SULFATE/0.7ML ATROPEN MERIDIAN MEDCL TECHN 017106 ATROPINE Injection 2MG SULFATE/0.7ML ATROPEN MERIDIAN MEDCL TECHN 021146 ATROPINE SULFATE Im-Iv-Sc 0.05MG/ML ATROPINE SULFATE ANSYR PLASTIC SYRINGE Abbott 021146 ATROPINE SULFATE Im-Iv-Sc 0.1MG/ML ATROPINE SULFATE ANSYR PLASTIC SYRINGE Abbott 017744 ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE Tablet; 0.025MG;1MG MOTOFEN AMARIN 086440 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE Capsule; 0.025MG;2.5MG DIPHENOXYLATE HCL W/ ATROPINE SULFATE SCHERER RP 012699 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE Solution; 0.025MG/5ML;2.5MG/5ML LOMOTIL GD SEARLE 087708 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE Solution; 0.025MG/5ML;2.5MG/5ML DIPHENOXYLATE HCL AND ATROPINE SULFATE Roxane 040395 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE Tablet; 0.025MG;2.5MG DIPHENOXYLATE HCL AND ATROPINE SULFATE Able 086173 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE Tablet; 0.025MG;2.5MG DIPHENOXYLATE HCL W/ ATROPINE SULFATE Eon 012462 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE Tablet; 0.025MG;2.5MG LOMOTIL GD SEARLE 085311 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE Tablet; 0.025MG;2.5MG LONOX Geneva 086727 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE Tablet; 0.025MG;2.5MG DIPHENOXYLATE HCL W/ ATROPINE SULFATE Ivax 085372 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE Tablet; 0.025MG;2.5MG DIPHENOXYLATE HCL AND ATROPINE SULFATE LANNETT 085762 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE Tablet; 0.025MG;2.5MG DIPHENOXYLATE HCL AND ATROPINE SULFATE Mylan 040357 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE Tablet; 0.025MG;2.5MG DIPHENOXYLATE HCL AND ATROPINE SULFATE Par 019677 ATROPINE SULFATE; EDROPHONIUM CHLORIDE Injection 0.14MG/ML;10MG/ML ENLON-PLUS Baxter CORP 019678 ATROPINE SULFATE; EDROPHONIUM CHLORIDE Injection 0.14MG/ML;10MG/ML ENLON-PLUS Baxter CORP 087848 ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE Injection 0.4MG/ML;100MG/ML ATROPINE AND DEMEROL Abbott 087853 ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE Injection 0.4MG/ML;50MG/ML ATROPINE AND DEMEROL Abbott 087847 ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE Injection 0.4MG/ML;75MG/ML ATROPINE AND DEMEROL Abbott 088017 HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE Syrup; 1.5MG/5ML;5MG/5ML HYDROCODONE COMPOUND ALPHARMA 040285 HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE Syrup; 1.5MG/5ML;5MG/5ML HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE AXIOM 005213 HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE Syrup; 1.5MG/5ML;5MG/5ML HYCODAN ENDO 088008 HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE Syrup; 1.5MG/5ML;5MG/5ML MYCODONE Morton Grove 040295 HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE Tablet; 1.5MG;5MG HOMATROPRINE METHYLBROMIDE AND HYDROCODONE BITARTRATE Amide 005213 HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE Tablet; 1.5MG;5MG HYCODAN ENDO 088508 HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE Tablet; 1.5MG;5MG TUSSIGON JONES | AtroPen (atropine) Injection, Meridian Medical, Formulation Revision | Lomotil (diphenoxylate hydrochloride) Liquid, Pfizer Inc., Labeling Revision | Lomotil (diphenoxylate hydrochloride and atropine sulfate) Tablets, Pfizer Inc., Labeling Revision | Duodote (atropine and pralidoxime chloride injection) Auto-Injector, Meridian Medical, Approval | Diphenoxylate HCL & Atropine Sulfate Tablets, Ivax Pharma, Facility Addition | Enlon Plus (edrophonium chloride and atropine sulfate) Injection, Bioniche Phara USA, LLC, Manufacturing Change or Addition | Duodote, atropine; pralidoxime chloride, Injectable; Intramuscular, Meridian Medcl, Manufacturing Change or Addition
  
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