Details for New Drug Application (NDA): 075562
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NDA 075562 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 075562
| Tradename: | IPRATROPIUM BROMIDE |
| Applicant: | Nephron |
| Ingredient: | ipratropium bromide |
| Patents: | 0 |
Pharmacology for NDA: 075562
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 075562
Suppliers and Packaging for NDA: 075562
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IPRATROPIUM BROMIDE | ipratropium bromide | SOLUTION;INHALATION | 075562 | ANDA | Nephron Pharmaceuticals Corporation | 0487-9801 | 0487-9801-01 | 30 POUCH in 1 CARTON (0487-9801-01) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE |
| IPRATROPIUM BROMIDE | ipratropium bromide | SOLUTION;INHALATION | 075562 | ANDA | Nephron Pharmaceuticals Corporation | 0487-9801 | 0487-9801-02 | 30 BAG in 1 BOX (0487-9801-02) / 1 POUCH in 1 BAG / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 0.02% | ||||
| Approval Date: | Sep 27, 2001 | TE: | AN | RLD: | No | ||||
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