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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. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the atropine profile page.

Summary for NDA: 017106

Tradename:
ATROPEN
Applicant:
Meridian Medcl Techn
Ingredient:
atropine
Patents:0
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
INJECTABLE;INJECTION 017106 NDA Meridian Medical Technologies, Inc. 11704-104 11704-104-01 .7 mL in 1 SYRINGE, GLASS (11704-104-01)
ATROPEN
atropine
INJECTABLE;INJECTION 017106 NDA Meridian Medical Technologies, Inc. 11704-105 11704-105-01 .7 mL in 1 SYRINGE, GLASS (11704-105-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2MG SULFATE/0.7ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1MG SULFATE/0.7ML
Approval Date:Jun 19, 2003TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.5MG SULFATE/0.7ML
Approval Date:Jun 19, 2003TE:RLD:Yes


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