Details for New Drug Application (NDA): 212197
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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 212197
Tradename: | ALBUTEROL SULFATE |
Applicant: | Quagen |
Ingredient: | albuterol sulfate |
Patents: | 0 |
Pharmacology for NDA: 212197
Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 212197
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | albuterol sulfate | SYRUP;ORAL | 212197 | ANDA | Preferred Pharmaceuticals, Inc. | 68788-7573 | 68788-7573-4 | 473 mL in 1 BOTTLE (68788-7573-4) |
ALBUTEROL SULFATE | albuterol sulfate | SYRUP;ORAL | 212197 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-102 | 70752-102-12 | 473 mL in 1 BOTTLE (70752-102-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | EQ 2MG BASE/5ML | ||||
Approval Date: | Sep 6, 2019 | TE: | AA | RLD: | No |
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