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Generated: September 22, 2017

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Details for New Drug Application (NDA): 087938

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NDA 087938 describes ISOETHARINE HYDROCHLORIDE, which is a drug marketed by Alpharma Us Pharms, Astrazeneca, Roxane, Baxter Hlthcare, Intl Medication, DEY, and Parke Davis, and is included in thirty-three NDAs. Additional details are available on the ISOETHARINE HYDROCHLORIDE profile page.

The generic ingredient in ISOETHARINE HYDROCHLORIDE is isoetharine hydrochloride. There are four drug master file entries for this compound. Additional details are available on the isoetharine hydrochloride profile page.

Summary for NDA: 087938

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INHALATIONStrength0.125%
Approval Date:Nov 15, 1982TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Moodys
Teva
Covington
Argus Health
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Healthtrust
Cerilliant
US Army

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