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Details for New Drug Application (NDA): 077519

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NDA 077519 describes BUDESONIDE, which is a drug marketed by Apotex Inc, Impax Labs Inc, Mylan, Teva Pharms, Mayne Pharma, Teva Pharms Usa, Sandoz Inc, and Barr Labs Div Teva, and is included in nine NDAs. It is available from twenty-two suppliers. Additional details are available on the BUDESONIDE profile page.

The generic ingredient in BUDESONIDE is budesonide. There are nineteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for NDA: 077519

Pharmacology for NDA: 077519

Suppliers and Packaging for NDA: 077519

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUDESONIDE
budesonide
SUSPENSION;INHALATION 077519 ANDA Teva Pharmaceuticals USA, Inc. 0093-6815 0093-6815-73 6 POUCH in 1 CARTON (0093-6815-73) > 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-6815-45) > 2 mL in 1 VIAL, SINGLE-DOSE
BUDESONIDE
budesonide
SUSPENSION;INHALATION 077519 ANDA Teva Pharmaceuticals USA, Inc. 0093-6815 0093-6815-76 2 POUCH in 1 CARTON (0093-6815-76) > 5 VIAL, SINGLE-DOSE in 1 POUCH > 2 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.25MG/2ML
Approval Date:Nov 18, 2008TE:ANRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.5MG/2ML
Approval Date:Nov 18, 2008TE:ANRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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