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Details for New Drug Application (NDA): 078202

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NDA 078202 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: 078202

Pharmacology for NDA: 078202

Suppliers and Packaging for NDA: 078202

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUDESONIDE
budesonide
SUSPENSION;INHALATION 078202 ANDA Nephron Pharmaceuticals Corporation 0487-9601 0487-9601-01 6 POUCH in 1 CARTON (0487-9601-01) > 5 AMPULE in 1 POUCH > 2 mL in 1 AMPULE
BUDESONIDE
budesonide
SUSPENSION;INHALATION 078202 ANDA Nephron Pharmaceuticals Corporation 0487-9601 0487-9601-30 30 POUCH in 1 CARTON (0487-9601-30) > 1 AMPULE in 1 POUCH > 2 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.25MG/2ML
Approval Date:Mar 30, 2009TE:ANRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INHALATIONStrength0.5MG/2ML
Approval Date:Mar 30, 2009TE:ANRLD:No


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