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Generated: January 22, 2019

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Details for New Drug Application (NDA): 017106

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NDA 017106 describes ATROPEN, which is a drug marketed by Meridian Medcl Techn and is included in one NDA. It is available from one supplier. Additional details are available on the ATROPEN profile page.

The generic ingredient in ATROPEN is atropine sulfate. There are twenty-three drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the atropine sulfate profile page.
Summary for 017106
Applicant:Meridian Medcl Techn
Ingredient:atropine sulfate
Formulation / Manufacturing:see details
Pharmacology for NDA: 017106
Suppliers and Packaging for NDA: 017106
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATROPEN atropine sulfate SOLUTION;INTRAMUSCULAR 017106 NDA Meridian Medical Technologies, Inc. 11704-104 11704-104-01 .7 mL in 1 SYRINGE, GLASS (11704-104-01)
ATROPEN atropine sulfate SOLUTION;INTRAMUSCULAR 017106 NDA Meridian Medical Technologies, Inc. 11704-105 11704-105-01 .7 mL in 1 SYRINGE, GLASS (11704-105-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULARStrength2MG/0.7ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULARStrength1MG/0.7ML
Approval Date:Jun 19, 2003TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULARStrength0.5MG/0.7ML
Approval Date:Jun 19, 2003TE:RLD:Yes

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