Details for New Drug Application (NDA): 072151
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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 072151
Tradename: | ALBUTEROL SULFATE |
Applicant: | Chartwell Rx |
Ingredient: | albuterol sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 072151
Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 072151
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 072151 | ANDA | Chartwell RX, LLC | 62135-671 | 62135-671-90 | 90 TABLET in 1 BOTTLE (62135-671-90) |
ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 072151 | ANDA | Chartwell RX, LLC | 62135-672 | 62135-672-90 | 90 TABLET in 1 BOTTLE (62135-672-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
Approval Date: | Dec 5, 1989 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Dec 5, 1989 | TE: | RLD: | No |
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