Details for New Drug Application (NDA): 214531
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The generic ingredient in ALBUTEROL SULFATE is albuterol sulfate; ipratropium bromide. There are thirty-eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
Summary for 214531
Tradename: | ALBUTEROL SULFATE |
Applicant: | Ritedose Corp |
Ingredient: | albuterol sulfate |
Patents: | 0 |
Pharmacology for NDA: 214531
Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 214531
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | albuterol sulfate | SOLUTION;INHALATION | 214531 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7057 | 0378-7057-52 | 5 POUCH in 1 CARTON (0378-7057-52) / 5 VIAL in 1 POUCH (0378-7057-98) / 3 mL in 1 VIAL |
ALBUTEROL SULFATE | albuterol sulfate | SOLUTION;INHALATION | 214531 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7058 | 0378-7058-52 | 5 POUCH in 1 CARTON (0378-7058-52) / 5 VIAL in 1 POUCH (0378-7058-98) / 3 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.021% BASE | ||||
Approval Date: | Dec 28, 2021 | TE: | AN | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.042% BASE | ||||
Approval Date: | Dec 28, 2021 | TE: | AN | RLD: | No |
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