Details for New Drug Application (NDA): 206543
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NDA 206543 describes IPRATROPIUM BROMIDE, which is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Bausch, Landela Pharm, Luoxin Aurovitas, Nephron, Pharmobedient, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms Usa, Watson Labs, Zennova, Amneal, Aurobindo Pharma Usa, Hikma, Lupin, and Rubicon Research, and is included in twenty-seven NDAs. It is available from twenty suppliers. Additional details are available on the IPRATROPIUM BROMIDE profile page.
The generic ingredient in IPRATROPIUM BROMIDE is ipratropium bromide. There are eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ipratropium bromide profile page.
The generic ingredient in IPRATROPIUM BROMIDE is ipratropium bromide. There are eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ipratropium bromide profile page.
Summary for 206543
| Tradename: | IPRATROPIUM BROMIDE |
| Applicant: | Luoxin Aurovitas |
| Ingredient: | ipratropium bromide |
| Patents: | 0 |
Pharmacology for NDA: 206543
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 206543
Suppliers and Packaging for NDA: 206543
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IPRATROPIUM BROMIDE | ipratropium bromide | SOLUTION;INHALATION | 206543 | ANDA | Aurobindo Pharma Limited | 65862-905 | 65862-905-03 | 30 POUCH in 1 CARTON (65862-905-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE |
| IPRATROPIUM BROMIDE | ipratropium bromide | SOLUTION;INHALATION | 206543 | ANDA | Aurobindo Pharma Limited | 65862-905 | 65862-905-25 | 1 POUCH in 1 CARTON (65862-905-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 0.02% | ||||
| Approval Date: | Oct 27, 2016 | TE: | AN | RLD: | No | ||||
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