Details for New Drug Application (NDA): 203409
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NDA 203409 describes TOLTERODINE TARTRATE, which is a drug marketed by Ajanta Pharma Ltd, Aurobindo Pharma Usa, Hetero Labs Ltd Iii, Inventia Hlthcare, Teva Pharms Usa, Torrent, Unichem, Utopic Pharms, Apotex Corp, Hetero Labs Ltd V, Ivax Sub Teva Pharms, Macleods Pharms, Pharmobedient, Rising, and Unique, and is included in sixteen NDAs. It is available from fourteen suppliers. Additional details are available on the TOLTERODINE TARTRATE profile page.
The generic ingredient in TOLTERODINE TARTRATE is tolterodine tartrate. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the tolterodine tartrate profile page.
The generic ingredient in TOLTERODINE TARTRATE is tolterodine tartrate. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the tolterodine tartrate profile page.
Summary for 203409
| Tradename: | TOLTERODINE TARTRATE |
| Applicant: | Macleods Pharms |
| Ingredient: | tolterodine tartrate |
| Patents: | 0 |
Pharmacology for NDA: 203409
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 203409
Suppliers and Packaging for NDA: 203409
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOLTERODINE TARTRATE | tolterodine tartrate | TABLET;ORAL | 203409 | ANDA | Macleods Pharmaceuticals Limited | 33342-097 | 33342-097-09 | 60 TABLET, FILM COATED in 1 BOTTLE (33342-097-09) |
| TOLTERODINE TARTRATE | tolterodine tartrate | TABLET;ORAL | 203409 | ANDA | Macleods Pharmaceuticals Limited | 33342-097 | 33342-097-12 | 10 BLISTER PACK in 1 CARTON (33342-097-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Aug 31, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Aug 31, 2015 | TE: | AB | RLD: | No | ||||
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