Details for New Drug Application (NDA): 207820
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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 207820
Tradename: | LEVALBUTEROL HYDROCHLORIDE |
Applicant: | Sun Pharm |
Ingredient: | levalbuterol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 207820
Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 207820
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVALBUTEROL HYDROCHLORIDE | levalbuterol hydrochloride | SOLUTION;INHALATION | 207820 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-743 | 47335-743-01 | 5 POUCH in 1 CARTON (47335-743-01) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE |
LEVALBUTEROL HYDROCHLORIDE | levalbuterol hydrochloride | SOLUTION;INHALATION | 207820 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-743 | 47335-743-49 | 2 POUCH in 1 CARTON (47335-743-49) / 12 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.0103% BASE | ||||
Approval Date: | Nov 5, 2018 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.021% BASE | ||||
Approval Date: | Nov 5, 2018 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.042% BASE | ||||
Approval Date: | Nov 5, 2018 | TE: | RLD: | No |
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