Details for New Drug Application (NDA): 203653
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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 203653
Tradename: | LEVALBUTEROL HYDROCHLORIDE |
Applicant: | Ritedose Corp |
Ingredient: | levalbuterol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 203653
Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 203653
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVALBUTEROL HYDROCHLORIDE | levalbuterol hydrochloride | SOLUTION;INHALATION | 203653 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-9930 | 0115-9930-78 | 1 POUCH in 1 CARTON (0115-9930-78) / 25 AMPULE in 1 POUCH (0115-9930-76) / 3 mL in 1 AMPULE |
LEVALBUTEROL HYDROCHLORIDE | levalbuterol hydrochloride | SOLUTION;INHALATION | 203653 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-9931 | 0115-9931-78 | 1 POUCH in 1 CARTON (0115-9931-78) / 25 AMPULE in 1 POUCH (0115-9931-76) / 3 mL in 1 AMPULE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.0103% BASE | ||||
Approval Date: | Mar 22, 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: | Mar 22, 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: | Mar 22, 2016 | TE: | AN | RLD: | No |
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