Details for New Drug Application (NDA): 078404
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NDA 078404 describes BUDESONIDE, which is a drug marketed by Padagis Israel, Amneal Pharms, Aurobindo Pharma Usa, Barr Labs Div Teva, Dr Reddys Labs Sa, Natco, Rising, Sciecure Pharma Inc, Zydus Pharms, Apotex Inc, Cipla, Eugia Pharma, Impax Labs Inc, Lupin, Nephron, Sandoz, Sun Pharm, Teva Pharms, Teva Pharms Usa, Actavis Labs Fl Inc, and Mylan, and is included in twenty-one NDAs. It is available from thirty-five suppliers. Additional details are available on the BUDESONIDE profile page.
The generic ingredient in BUDESONIDE is budesonide. There are twenty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the budesonide profile page.
The generic ingredient in BUDESONIDE is budesonide. There are twenty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 078404
| Tradename: | BUDESONIDE |
| Applicant: | Impax Labs Inc |
| Ingredient: | budesonide |
| Patents: | 0 |
Pharmacology for NDA: 078404
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 078404
Suppliers and Packaging for NDA: 078404
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUDESONIDE | budesonide | SUSPENSION;INHALATION | 078404 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1687 | 0115-1687-74 | 6 POUCH in 1 CARTON (0115-1687-74) / 5 VIAL in 1 POUCH (0115-1687-76) / 2 mL in 1 VIAL |
| BUDESONIDE | budesonide | SUSPENSION;INHALATION | 078404 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1689 | 0115-1689-74 | 6 POUCH in 1 CARTON (0115-1689-74) / 5 VIAL in 1 POUCH (0115-1689-76) / 2 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;INHALATION | Strength | 0.25MG/2ML | ||||
| Approval Date: | Jul 31, 2012 | TE: | AN | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;INHALATION | Strength | 0.5MG/2ML | ||||
| Approval Date: | Jul 31, 2012 | TE: | AN | RLD: | No | ||||
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