Details for New Drug Application (NDA): 075693
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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 075693
Tradename: | IPRATROPIUM BROMIDE |
Applicant: | Ritedose Corp |
Ingredient: | ipratropium bromide |
Patents: | 0 |
Pharmacology for NDA: 075693
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 075693
Suppliers and Packaging for NDA: 075693
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IPRATROPIUM BROMIDE | ipratropium bromide | SOLUTION;INHALATION | 075693 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7970 | 0378-7970-52 | 1 POUCH in 1 CARTON (0378-7970-52) / 25 AMPULE in 1 POUCH (0378-7970-62) / 2.5 mL in 1 AMPULE |
IPRATROPIUM BROMIDE | ipratropium bromide | SOLUTION;INHALATION | 075693 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7970 | 0378-7970-55 | 30 POUCH in 1 CARTON (0378-7970-55) / 1 AMPULE in 1 POUCH (0378-7970-31) / 2.5 mL in 1 AMPULE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 0.02% | ||||
Approval Date: | Jan 26, 2001 | TE: | AN | RLD: | No |
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