Details for New Drug Application (NDA): 020929
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The generic ingredient in PULMICORT RESPULES is budesonide. There is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 020929
| Tradename: | PULMICORT RESPULES |
| Applicant: | Astrazeneca |
| Ingredient: | budesonide |
| Patents: | 0 |
Pharmacology for NDA: 020929
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 020929
Suppliers and Packaging for NDA: 020929
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929 | NDA | AstraZeneca Pharmaceuticals LP | 0186-1988 | 0186-1988-04 | 6 POUCH in 1 CARTON (0186-1988-04) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE |
| PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929 | NDA | AstraZeneca Pharmaceuticals LP | 0186-1989 | 0186-1989-04 | 6 POUCH in 1 CARTON (0186-1989-04) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;INHALATION | Strength | 0.25MG/2ML | ||||
| Approval Date: | Aug 8, 2000 | TE: | AN | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;INHALATION | Strength | 0.5MG/2ML | ||||
| Approval Date: | Aug 8, 2000 | TE: | AN | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;INHALATION | Strength | 1MG/2ML | ||||
| Approval Date: | Aug 8, 2000 | TE: | AN | RLD: | Yes | ||||
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