Details for New Drug Application (NDA): 205710
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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 205710
Tradename: | BUDESONIDE |
Applicant: | Cipla |
Ingredient: | budesonide |
Patents: | 0 |
Pharmacology for NDA: 205710
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 205710
Suppliers and Packaging for NDA: 205710
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUDESONIDE | budesonide | SUSPENSION;INHALATION | 205710 | ANDA | NorthStar RxLLC | 16714-018 | 16714-018-30 | 6 POUCH in 1 CARTON (16714-018-30) / 5 AMPULE in 1 POUCH (16714-018-05) / 2 mL in 1 AMPULE |
BUDESONIDE | budesonide | SUSPENSION;INHALATION | 205710 | ANDA | NorthStar RxLLC | 16714-019 | 16714-019-30 | 6 POUCH in 1 CARTON (16714-019-30) / 5 AMPULE in 1 POUCH (16714-019-05) / 2 mL in 1 AMPULE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;INHALATION | Strength | 0.25MG/2ML | ||||
Approval Date: | Nov 16, 2017 | TE: | AN | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;INHALATION | Strength | 0.5MG/2ML | ||||
Approval Date: | Nov 16, 2017 | TE: | AN | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;INHALATION | Strength | 1MG/2ML | ||||
Approval Date: | Nov 16, 2017 | TE: | AN | RLD: | No |
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