Details for New Drug Application (NDA): 206532
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The generic ingredient in ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE 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 206532
Tradename: | ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE |
Applicant: | Luoxin Aurovitas |
Ingredient: | albuterol sulfate; ipratropium bromide |
Patents: | 0 |
Pharmacology for NDA: 206532
Mechanism of Action | Adrenergic beta2-Agonists Cholinergic Antagonists |
Suppliers and Packaging for NDA: 206532
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | albuterol sulfate; ipratropium bromide | SOLUTION;INHALATION | 206532 | ANDA | Aurobindo Pharma Limited | 65862-906 | 65862-906-03 | 30 POUCH in 1 CARTON (65862-906-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-01) / 3 mL in 1 VIAL, SINGLE-DOSE |
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | albuterol sulfate; ipratropium bromide | SOLUTION;INHALATION | 206532 | ANDA | Aurobindo Pharma Limited | 65862-906 | 65862-906-30 | 6 POUCH in 1 CARTON (65862-906-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-05) / 3 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.083% BASE;0.017% | ||||
Approval Date: | Jul 8, 2020 | TE: | RLD: | No |
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