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Last Updated: April 21, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078630

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NDA 078630 describes TERBUTALINE SULFATE, which is a drug marketed by Akorn, Athenex Inc, 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 ten 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. Eleven suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.
Summary for 078630
Applicant:Hikma Farmaceutica
Ingredient:terbutaline sulfate
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078630
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERBUTALINE SULFATE terbutaline sulfate INJECTABLE;INJECTION 078630 ANDA Hikma Pharmaceuticals USA Inc. 0143-9375 0143-9375-10 10 VIAL in 1 CARTON (0143-9375-10) > 1 mL in 1 VIAL (0143-9375-01)
TERBUTALINE SULFATE terbutaline sulfate INJECTABLE;INJECTION 078630 ANDA West-Ward Pharmaceuticals Corp 0143-9746 0143-9746-10 10 VIAL in 1 CARTON (0143-9746-10) > 1 mL in 1 VIAL (0143-9746-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:May 20, 2009TE:APRLD:No

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