Details for New Drug Application (NDA): 215104
✉ Email this page to a colleague
NDA 215104 describes IPRATROPIUM BROMIDE, which is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Bausch, Landela Pharm, Luoxin Aurovitas, Nephron, Norvium Bioscience, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms Usa, Watson Labs, Zennova, Amneal, Aurobindo Pharma Usa, and Hikma, and is included in twenty-three NDAs. It is available from seventeen suppliers. Additional details are available on the IPRATROPIUM BROMIDE profile page.
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.
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 215104
| Tradename: | IPRATROPIUM BROMIDE |
| Applicant: | Amneal |
| Ingredient: | ipratropium bromide |
| Patents: | 0 |
Pharmacology for NDA: 215104
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 215104
Suppliers and Packaging for NDA: 215104
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IPRATROPIUM BROMIDE | ipratropium bromide | SPRAY, METERED;NASAL | 215104 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2016 | 69238-2016-3 | 1 BOTTLE, SPRAY in 1 CARTON (69238-2016-3) / 345 SPRAY in 1 BOTTLE, SPRAY |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.021MG/SPRAY | ||||
| Approval Date: | Aug 16, 2022 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
