Details for New Drug Application (NDA): 091688
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NDA 091688 describes TROSPIUM CHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Granules, Padagis Us, Upsher Smith Labs, Utopic Pharms, Apotex, Glenmark Pharms Ltd, Heritage Pharms Inc, Invagen Pharms, Macleods Pharms Ltd, and Zameer Pharms, and is included in twelve 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 091688
| Tradename: | TROSPIUM CHLORIDE |
| Applicant: | Invagen Pharms |
| Ingredient: | trospium chloride |
| Patents: | 0 |
Pharmacology for NDA: 091688
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 091688
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TROSPIUM CHLORIDE | trospium chloride | TABLET;ORAL | 091688 | ANDA | CIPLA USA INC., | 69097-912 | 69097-912-02 | 30 TABLET, FILM COATED in 1 BOTTLE (69097-912-02) |
| TROSPIUM CHLORIDE | trospium chloride | TABLET;ORAL | 091688 | ANDA | CIPLA USA INC., | 69097-912 | 69097-912-03 | 60 TABLET, FILM COATED in 1 BOTTLE (69097-912-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Aug 23, 2016 | TE: | AB | RLD: | No | ||||
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