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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021146

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NDA 021146 describes ATROPINE SULFATE ANSYR PLASTIC SYRINGE, which is a drug marketed by Hospira and is included in one NDA. It is available from two suppliers. Additional details are available on the ATROPINE SULFATE ANSYR PLASTIC SYRINGE profile page.

The generic ingredient in ATROPINE SULFATE ANSYR PLASTIC SYRINGE is atropine sulfate. There are twenty-three drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the atropine sulfate profile page.
Summary for 021146
Tradename:ATROPINE SULFATE ANSYR PLASTIC SYRINGE
Applicant:Hospira
Ingredient:atropine sulfate
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021146
Suppliers and Packaging for NDA: 021146
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATROPINE SULFATE LIFESHIELD ABBOJECT SYRINGE atropine sulfate SOLUTION;INTRAVENOUS 021146 NDA Hospira, Inc. 0409-1630 N 0409-1630-10
ATROPINE SULFATE ANSYR PLASTIC SYRINGE atropine sulfate SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEAL 021146 NDA Hospira, Inc. 0409-1630 N 0409-1630-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEALStrength0.5MG/5ML (0.1MG/ML)
Approval Date:Jul 9, 2001TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEALStrength0.25MG/5ML (0.05MG/ML)
Approval Date:Jul 9, 2001TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEALStrength1MG/10ML (0.1MG/ML)
Approval Date:Jul 9, 2001TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
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