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Last Updated: October 6, 2022

Details for New Drug Application (NDA): 075877


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NDA 075877 describes TERBUTALINE SULFATE, which is a drug marketed by Akorn, Chartwell Injectable, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, United Biomedcl, Impax Labs, Lannett Co Inc, and Twi Pharms, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the TERBUTALINE SULFATE profile page.

The generic ingredient in TERBUTALINE SULFATE is terbutaline sulfate. There are seven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.
Summary for 075877
Tradename:TERBUTALINE SULFATE
Applicant:Impax Labs
Ingredient:terbutaline sulfate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 075877
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERBUTALINE SULFATE terbutaline sulfate TABLET;ORAL 075877 ANDA Amneal Pharmaceuticals of New York LLC 0115-2611 0115-2611-01 100 TABLET in 1 BOTTLE (0115-2611-01)
TERBUTALINE SULFATE terbutaline sulfate TABLET;ORAL 075877 ANDA Amneal Pharmaceuticals of New York LLC 0115-2611 0115-2611-02 500 TABLET in 1 BOTTLE (0115-2611-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Jun 26, 2001TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 26, 2001TE:ABRLD:No

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