Details for New Drug Application (NDA): 202496
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NDA 202496 describes ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, which is a drug marketed by Apotex Inc, Cipla, Fosun Pharma, Luoxin Aurovitas, Nephron, Ritedose Corp, Sun Pharm, Teva Pharms, and Watson Labs Teva, and is included in nine NDAs. It is available from fourteen suppliers. Additional details are available on the ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE profile page.
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.
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 202496
| Tradename: | ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE |
| Applicant: | Ritedose Corp |
| Ingredient: | albuterol sulfate; ipratropium bromide |
| Patents: | 0 |
Pharmacology for NDA: 202496
| Mechanism of Action | Adrenergic beta2-Agonists Cholinergic Antagonists |
Suppliers and Packaging for NDA: 202496
| 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 | 202496 | ANDA | Mylan Pharmaceuticals Inc. | 0378-9671 | 0378-9671-30 | 1 POUCH in 1 CARTON (0378-9671-30) / 30 AMPULE in 1 POUCH (0378-9671-64) / 3 mL in 1 AMPULE |
| ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | albuterol sulfate; ipratropium bromide | SOLUTION;INHALATION | 202496 | ANDA | Mylan Pharmaceuticals Inc. | 0378-9671 | 0378-9671-60 | 2 POUCH in 1 CARTON (0378-9671-60) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.083% BASE;0.017% | ||||
| Approval Date: | Oct 1, 2012 | TE: | AN | RLD: | No | ||||
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