Details for New Drug Application (NDA): 215105
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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 215105
Tradename: | IPRATROPIUM BROMIDE |
Applicant: | Amneal |
Ingredient: | ipratropium bromide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215105
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 215105
Suppliers and Packaging for NDA: 215105
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IPRATROPIUM BROMIDE | ipratropium bromide | SPRAY, METERED;NASAL | 215105 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2017 | 69238-2017-2 | 1 BOTTLE, SPRAY in 1 CARTON (69238-2017-2) / 165 SPRAY in 1 BOTTLE, SPRAY |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.042MG/SPRAY | ||||
Approval Date: | Aug 16, 2022 | TE: | AB | RLD: | No |
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