Details for New Drug Application (NDA): 020929
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NDA 020929 describes PULMICORT RESPULES, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. Additional details are available on the PULMICORT RESPULES profile page.
The generic ingredient in PULMICORT RESPULES 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 PULMICORT RESPULES 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 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 | ||||
Expired US Patents for NDA 020929
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-003 | Aug 8, 2000 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-002 | Aug 8, 2000 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-003 | Aug 8, 2000 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-001 | Aug 8, 2000 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-002 | Aug 8, 2000 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca | PULMICORT RESPULES | budesonide | SUSPENSION;INHALATION | 020929-003 | Aug 8, 2000 | ⤷ Subscribe | ⤷ Subscribe |
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