Details for New Drug Application (NDA): 077559
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The generic ingredient in ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE 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 077559
Tradename: | ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE |
Applicant: | Cipla |
Ingredient: | albuterol sulfate; ipratropium bromide |
Patents: | 0 |
Pharmacology for NDA: 077559
Mechanism of Action | Adrenergic beta2-Agonists Cholinergic Antagonists |
Suppliers and Packaging for NDA: 077559
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | albuterol sulfate; ipratropium bromide | SOLUTION;INHALATION | 077559 | ANDA | Cipla USA Inc. | 69097-173 | 69097-173-53 | 6 POUCH in 1 CARTON (69097-173-53) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL |
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | albuterol sulfate; ipratropium bromide | SOLUTION;INHALATION | 077559 | ANDA | Cipla USA Inc. | 69097-173 | 69097-173-64 | 12 POUCH in 1 CARTON (69097-173-64) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.083% BASE;0.017% | ||||
Approval Date: | Dec 31, 2007 | TE: | AN | RLD: | No |
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