Details for New Drug Application (NDA): 090297
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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 090297
Tradename: | LEVALBUTEROL HYDROCHLORIDE |
Applicant: | Teva Pharms Usa |
Ingredient: | levalbuterol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 090297
Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 090297
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVALBUTEROL HYDROCHLORIDE | levalbuterol hydrochloride | SOLUTION;INHALATION | 090297 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-4145 | 0093-4145-56 | 6 POUCH in 1 CARTON (0093-4145-56) / 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4145-45) / 3 mL in 1 VIAL, SINGLE-DOSE |
LEVALBUTEROL HYDROCHLORIDE | levalbuterol hydrochloride | SOLUTION;INHALATION | 090297 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-4146 | 0093-4146-56 | 6 POUCH in 1 CARTON (0093-4146-56) / 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4146-45) / 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: | Apr 26, 2013 | TE: | AN | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.021% BASE | ||||
Approval Date: | Apr 26, 2013 | TE: | AN | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.042% BASE | ||||
Approval Date: | Apr 26, 2013 | TE: | AN | RLD: | No |
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