Details for New Drug Application (NDA): 076155
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The generic ingredient in IPRATROPIUM BROMIDE is ipratropium bromide. There are eight drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the ipratropium bromide profile page.
Summary for 076155
Tradename: | IPRATROPIUM BROMIDE |
Applicant: | Apotex Inc |
Ingredient: | ipratropium bromide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076155
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 076155
Suppliers and Packaging for NDA: 076155
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IPRATROPIUM BROMIDE | ipratropium bromide | SPRAY, METERED;NASAL | 076155 | ANDA | NORTHSTAR RX LLC | 16714-527 | 16714-527-01 | 1 BOTTLE, PUMP in 1 CARTON (16714-527-01) / 165 SPRAY, METERED in 1 BOTTLE, PUMP |
IPRATROPIUM BROMIDE | ipratropium bromide | SPRAY, METERED;NASAL | 076155 | ANDA | A-S Medication Solutions | 50090-5968 | 50090-5968-0 | 1 BOTTLE, PUMP in 1 CARTON (50090-5968-0) / 165 SPRAY, METERED in 1 BOTTLE, PUMP |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.042MG/SPRAY | ||||
Approval Date: | Apr 18, 2003 | TE: | AB | RLD: | No |
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