Details for New Drug Application (NDA): 076598
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NDA 076598 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 076598
| Tradename: | IPRATROPIUM BROMIDE |
| Applicant: | Hikma |
| Ingredient: | ipratropium bromide |
| Patents: | 0 |
Pharmacology for NDA: 076598
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 076598
Suppliers and Packaging for NDA: 076598
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IPRATROPIUM BROMIDE | ipratropium bromide | SPRAY, METERED;NASAL | 076598 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0046 | 0054-0046-41 | 1 BOTTLE, SPRAY in 1 CARTON (0054-0046-41) / 165 SPRAY in 1 BOTTLE, SPRAY |
| IPRATROPIUM BROMIDE | ipratropium bromide | SPRAY, METERED;NASAL | 076598 | ANDA | Bryant Ranch Prepack | 72162-2144 | 72162-2144-2 | 1 BOTTLE, SPRAY in 1 CARTON (72162-2144-2) / 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: | Nov 5, 2003 | TE: | AB | RLD: | No | ||||
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