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Details for New Drug Application (NDA): 201966

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NDA 201966 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-one suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Pharmacology for NDA: 201966

Suppliers and Packaging for NDA: 201966

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSPENSION;INHALATION 201966 ANDA Sandoz Inc 0781-7515 0781-7515-87 6 POUCH in 1 CARTON (0781-7515-87) > 5 AMPULE in 1 POUCH (0781-7515-14) > 2 mL in 1 AMPULE
SUSPENSION;INHALATION 201966 ANDA Sandoz Inc 0781-7516 0781-7516-87 6 POUCH in 1 CARTON (0781-7516-87) > 5 AMPULE in 1 POUCH (0781-7516-14) > 2 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength1MG/2ML
Approval Date:Sep 27, 2013TE:ANRLD:No
Regulatory Exclusivity Expiration:Jan 23, 2016
Regulatory Exclusivity Use:PATENT CHALLENGE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.5MG/2ML
Approval Date:Sep 27, 2013TE:ANRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.25MG/2ML
Approval Date:Sep 27, 2013TE: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.