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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 200122


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NDA 200122 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 200122
Tradename:TERBUTALINE SULFATE
Applicant:United Biomedcl
Ingredient:terbutaline sulfate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 200122
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERBUTALINE SULFATE terbutaline sulfate INJECTABLE;INJECTION 200122 ANDA Medical Purchasing Solutions, LLC 71872-7130 71872-7130-1 1 VIAL in 1 BAG (71872-7130-1) / 1 mL in 1 VIAL
TERBUTALINE SULFATE terbutaline sulfate INJECTABLE;INJECTION 200122 ANDA UBI Pharma Inc. 72843-101 72843-101-10 10 VIAL in 1 BOX (72843-101-10) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Nov 8, 2013TE:APRLD:No

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