Details for New Drug Application (NDA): 211922
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NDA 211922 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-four 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-three 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-three suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 211922
| Tradename: | BUDESONIDE |
| Applicant: | Sun Pharm |
| Ingredient: | budesonide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211922
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 211922
Suppliers and Packaging for NDA: 211922
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUDESONIDE | budesonide | SUSPENSION;INHALATION | 211922 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-631 | 47335-631-49 | 6 POUCH in 1 CARTON (47335-631-49) / 5 AMPULE in 1 POUCH (47335-631-48) / 2 mL in 1 AMPULE |
| BUDESONIDE | budesonide | SUSPENSION;INHALATION | 211922 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-632 | 47335-632-49 | 6 POUCH in 1 CARTON (47335-632-49) / 5 AMPULE in 1 POUCH (47335-632-48) / 2 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;INHALATION | Strength | 0.25MG/2ML | ||||
| Approval Date: | Apr 14, 2021 | TE: | AN | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;INHALATION | Strength | 0.5MG/2ML | ||||
| Approval Date: | Apr 14, 2021 | TE: | AN | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;INHALATION | Strength | 1MG/2ML | ||||
| Approval Date: | Apr 14, 2021 | TE: | AN | RLD: | No | ||||
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