Details for New Drug Application (NDA): 210948
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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 210948
Tradename: | ALBUTEROL SULFATE |
Applicant: | Aizant |
Ingredient: | albuterol sulfate |
Patents: | 0 |
Pharmacology for NDA: 210948
Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 210948
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 210948 | ANDA | Nivagen Pharmaceuticals Inc | 75834-273 | 75834-273-01 | 100 TABLET in 1 BOTTLE, PLASTIC (75834-273-01) |
ALBUTEROL SULFATE | albuterol sulfate | TABLET;ORAL | 210948 | ANDA | Nivagen Pharmaceuticals Inc | 75834-274 | 75834-274-01 | 100 TABLET in 1 BOTTLE, PLASTIC (75834-274-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
Approval Date: | Mar 15, 2019 | TE: | BX | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Mar 15, 2019 | TE: | BX | RLD: | No |
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