Details for New Drug Application (NDA): 203653
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NDA 203653 describes LEVALBUTEROL HYDROCHLORIDE, which is a drug marketed by Cipla, Impax Labs Inc, Luoxin Aurovitas, Mankind Pharma, Mylan Speciality Lp, Norvium Bioscience, Ritedose Corp, Sun Pharm, Teva Parenteral, and Teva Pharms Usa, and is included in eleven NDAs. It is available from eleven suppliers. Additional details are available on the LEVALBUTEROL HYDROCHLORIDE profile page.
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.
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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