Details for New Drug Application (NDA): 091289
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NDA 091289 describes TROSPIUM CHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Amta, Granules, Padagis Us, Upsher Smith Labs, Apotex, Glenmark Generics, Heritage Pharms Inc, Invagen Pharms, and Zameer Pharms, and is included in eleven NDAs. It is available from eighteen suppliers. Additional details are available on the TROSPIUM CHLORIDE profile page.
The generic ingredient in TROSPIUM CHLORIDE is trospium chloride. There are sixteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the trospium chloride profile page.
The generic ingredient in TROSPIUM CHLORIDE is trospium chloride. There are sixteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the trospium chloride profile page.
Summary for 091289
| Tradename: | TROSPIUM CHLORIDE |
| Applicant: | Actavis Labs Fl Inc |
| Ingredient: | trospium chloride |
| Patents: | 0 |
Pharmacology for NDA: 091289
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 091289
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TROSPIUM CHLORIDE | trospium chloride | CAPSULE, EXTENDED RELEASE;ORAL | 091289 | ANDA | Actavis Pharma, Inc. | 0591-3636 | 0591-3636-05 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3636-05) |
| TROSPIUM CHLORIDE | trospium chloride | CAPSULE, EXTENDED RELEASE;ORAL | 091289 | ANDA | Actavis Pharma, Inc. | 0591-3636 | 0591-3636-30 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3636-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
| Approval Date: | Oct 12, 2012 | TE: | AB | RLD: | No | ||||
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