Details for New Drug Application (NDA): 076156
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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 076156
Tradename: | IPRATROPIUM BROMIDE |
Applicant: | Apotex Inc |
Ingredient: | ipratropium bromide |
Patents: | 0 |
Pharmacology for NDA: 076156
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 076156
Suppliers and Packaging for NDA: 076156
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IPRATROPIUM BROMIDE | ipratropium bromide | SPRAY, METERED;NASAL | 076156 | ANDA | NORTHSTAR RX LLC | 16714-526 | 16714-526-01 | 1 BOTTLE, SPRAY in 1 CARTON (16714-526-01) / 345 SPRAY, METERED in 1 BOTTLE, SPRAY |
IPRATROPIUM BROMIDE | ipratropium bromide | SPRAY, METERED;NASAL | 076156 | ANDA | Apotex Corp. | 60505-0826 | 60505-0826-1 | 1 BOTTLE, SPRAY in 1 CARTON (60505-0826-1) / 345 SPRAY, METERED in 1 BOTTLE, SPRAY |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.021MG/SPRAY | ||||
Approval Date: | Apr 18, 2003 | TE: | AB | RLD: | No |
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