Details for New Drug Application (NDA): 021949
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NDA 021949 describes PULMICORT FLEXHALER, which is a drug marketed by Cheplapharm and is included in one NDA. It is available from three suppliers. Additional details are available on the PULMICORT FLEXHALER profile page.
The generic ingredient in PULMICORT FLEXHALER 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.
The generic ingredient in PULMICORT FLEXHALER 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 021949
| Tradename: | PULMICORT FLEXHALER |
| Applicant: | Cheplapharm |
| Ingredient: | budesonide |
| Patents: | 0 |
Pharmacology for NDA: 021949
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 021949
Suppliers and Packaging for NDA: 021949
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949 | NDA | A-S Medication Solutions | 50090-2239 | 50090-2239-0 | 1 INHALER in 1 CARTON (50090-2239-0) / 120 AEROSOL, POWDER in 1 INHALER |
| PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949 | NDA | A-S Medication Solutions | 50090-6796 | 50090-6796-0 | 1 INHALER in 1 CARTON (50090-6796-0) / 120 AEROSOL, POWDER in 1 INHALER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER, METERED;INHALATION | Strength | 0.08MG/INH | ||||
| Approval Date: | Jul 12, 2006 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER, METERED;INHALATION | Strength | 0.16MG/INH | ||||
| Approval Date: | Jul 12, 2006 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021949
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cheplapharm | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-001 | Jul 12, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Cheplapharm | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-002 | Jul 12, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Cheplapharm | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-002 | Jul 12, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Cheplapharm | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-002 | Jul 12, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Cheplapharm | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-001 | Jul 12, 2006 | ⤷ Start Trial | ⤷ Start Trial |
| Cheplapharm | PULMICORT FLEXHALER | budesonide | POWDER, METERED;INHALATION | 021949-001 | Jul 12, 2006 | ⤷ Start Trial | ⤷ Start Trial |
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