Details for New Drug Application (NDA): 201291
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NDA 201291 describes TROSPIUM CHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Granules, Padagis Us, Upsher Smith Labs, Utopic Pharms, Apotex, Chartwell Rx, Glenmark Pharms Ltd, Heritage Pharms Inc, Invagen Pharms, and Macleods Pharms Ltd, and is included in twelve NDAs. It is available from nineteen 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. Nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the trospium chloride profile page.
Summary for 201291
| Tradename: | TROSPIUM CHLORIDE |
| Applicant: | Padagis Us |
| Ingredient: | trospium chloride |
| Patents: | 0 |
Pharmacology for NDA: 201291
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 201291
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TROSPIUM CHLORIDE | trospium chloride | CAPSULE, EXTENDED RELEASE;ORAL | 201291 | ANDA | Padagis US LLC | 0574-0118 | 0574-0118-30 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0574-0118-30) |
| TROSPIUM CHLORIDE | trospium chloride | CAPSULE, EXTENDED RELEASE;ORAL | 201291 | ANDA | Bryant Ranch Prepack | 63629-8458 | 63629-8458-1 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8458-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
| Approval Date: | May 24, 2013 | TE: | AB | RLD: | No | ||||
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