Details for New Drug Application (NDA): 078171
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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 078171
Tradename: | LEVALBUTEROL HYDROCHLORIDE |
Applicant: | Cipla |
Ingredient: | levalbuterol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 078171
Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 078171
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVALBUTEROL HYDROCHLORIDE | levalbuterol hydrochloride | SOLUTION;INHALATION | 078171 | ANDA | Dr. Reddy?s Laboratories, Inc. | 43598-409 | 43598-409-25 | 5 POUCH in 1 CARTON (43598-409-25) / 5 VIAL in 1 POUCH (43598-409-05) / 3 mL in 1 VIAL |
LEVALBUTEROL HYDROCHLORIDE | levalbuterol hydrochloride | SOLUTION;INHALATION | 078171 | ANDA | Dr. Reddy?s Laboratories, Inc. | 43598-410 | 43598-410-25 | 5 POUCH in 1 CARTON (43598-410-25) / 5 VIAL in 1 POUCH (43598-410-05) / 3 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.0103% BASE | ||||
Approval Date: | Dec 13, 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: | Dec 13, 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: | Dec 13, 2013 | TE: | AN | RLD: | No |
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