Details for New Drug Application (NDA): 206543
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The generic ingredient in IPRATROPIUM BROMIDE is ipratropium bromide. There are eight drug master file entries for this compound. Eighteen 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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