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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 076853


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NDA 076853 describes TERBUTALINE SULFATE, which is a drug marketed by Chartwell Injectable, Dr Reddys, Epic Pharma Llc, 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 twelve 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. Thirteen suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.
Summary for 076853
Tradename:TERBUTALINE SULFATE
Applicant:Dr Reddys
Ingredient:terbutaline sulfate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Jul 20, 2004TE:RLD:No

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