Details for New Drug Application (NDA): 206224
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The generic ingredient in ALBUTEROL SULFATE is albuterol sulfate; ipratropium bromide. There are thirty-eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
Summary for 206224
Tradename: | ALBUTEROL SULFATE |
Applicant: | Luoxin Aurovitas |
Ingredient: | albuterol sulfate |
Patents: | 0 |
Pharmacology for NDA: 206224
Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 206224
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | albuterol sulfate | SOLUTION;INHALATION | 206224 | ANDA | Aurobindo Pharma Limited | 65862-858 | 65862-858-03 | 30 POUCH in 1 CARTON (65862-858-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE |
ALBUTEROL SULFATE | albuterol sulfate | SOLUTION;INHALATION | 206224 | ANDA | Aurobindo Pharma Limited | 65862-858 | 65862-858-25 | 5 POUCH in 1 CARTON (65862-858-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.083% BASE | ||||
Approval Date: | Oct 17, 2017 | TE: | AN | RLD: | No |
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