Details for New Drug Application (NDA): 204562
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NDA 204562 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 204562
| Tradename: | TOLTERODINE TARTRATE |
| Applicant: | Inventia Hlthcare |
| Ingredient: | tolterodine tartrate |
| Patents: | 0 |
Pharmacology for NDA: 204562
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 204562
Suppliers and Packaging for NDA: 204562
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOLTERODINE TARTRATE | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 204562 | ANDA | Major Pharmaceuticals | 0904-7574 | 0904-7574-04 | 30 BLISTER PACK in 1 CARTON (0904-7574-04) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK |
| TOLTERODINE TARTRATE | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 204562 | ANDA | Major Pharmaceuticals | 0904-7575 | 0904-7575-04 | 30 BLISTER PACK in 1 CARTON (0904-7575-04) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 2MG | ||||
| Approval Date: | Aug 19, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 4MG | ||||
| Approval Date: | Aug 19, 2019 | TE: | AB | RLD: | No | ||||
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