Details for New Drug Application (NDA): 076103
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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 076103
Tradename: | IPRATROPIUM BROMIDE |
Applicant: | Bausch |
Ingredient: | ipratropium bromide |
Patents: | 0 |
Pharmacology for NDA: 076103
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 076103
Suppliers and Packaging for NDA: 076103
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IPRATROPIUM BROMIDE | ipratropium bromide | SPRAY, METERED;NASAL | 076103 | ANDA | Bausch & Lomb Incorporated | 24208-399 | 24208-399-15 | 1 BOTTLE, SPRAY in 1 CARTON (24208-399-15) / 165 SPRAY, METERED in 1 BOTTLE, SPRAY |
IPRATROPIUM BROMIDE | ipratropium bromide | SPRAY, METERED;NASAL | 076103 | ANDA | RPK Pharmaceuticals, Inc. | 53002-7880 | 53002-7880-1 | 165 SPRAY, METERED in 1 BOTTLE, SPRAY (53002-7880-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.042MG/SPRAY | ||||
Approval Date: | Mar 31, 2003 | TE: | AB | RLD: | No |
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