Details for New Drug Application (NDA): 207625
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The generic ingredient in LEVALBUTEROL HYDROCHLORIDE is levalbuterol hydrochloride. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the levalbuterol hydrochloride profile page.
Summary for 207625
Tradename: | LEVALBUTEROL HYDROCHLORIDE |
Applicant: | Luoxin Aurovitas |
Ingredient: | levalbuterol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 207625
Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 207625
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVALBUTEROL HYDROCHLORIDE | levalbuterol hydrochloride | SOLUTION;INHALATION | 207625 | ANDA | Aurobindo Pharma Limited | 65862-943 | 65862-943-24 | 2 POUCH in 1 CARTON (65862-943-24) / 12 VIAL, SINGLE-DOSE in 1 POUCH (65862-943-12) / 3 mL in 1 VIAL, SINGLE-DOSE |
LEVALBUTEROL HYDROCHLORIDE | levalbuterol hydrochloride | SOLUTION;INHALATION | 207625 | ANDA | Aurobindo Pharma Limited | 65862-944 | 65862-944-24 | 2 POUCH in 1 CARTON (65862-944-24) / 12 VIAL, SINGLE-DOSE in 1 POUCH (65862-944-12) / 3 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.0103% BASE | ||||
Approval Date: | Dec 30, 2016 | TE: | AN | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.021% BASE | ||||
Approval Date: | Dec 30, 2016 | TE: | AN | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.042% BASE | ||||
Approval Date: | Dec 30, 2016 | TE: | AN | RLD: | No |
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