Details for New Drug Application (NDA): 213397
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NDA 213397 describes TOLTERODINE TARTRATE, which is a drug marketed by Ajanta Pharma Ltd, Amta, Aurobindo Pharma Usa, Hetero Labs Ltd Iii, Inventia Hlthcare, Teva Pharms Usa, Torrent, Apotex Corp, Elysium, Hetero Labs Ltd V, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Mylan Pharms Inc, Unichem, and Unique, and is included in fifteen NDAs. It is available from sixteen suppliers. Additional details are available on the TOLTERODINE TARTRATE profile page.
The generic ingredient in TOLTERODINE TARTRATE is tolterodine tartrate. There are twenty-three drug master file entries for this compound. Twenty 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 are twenty-three drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the tolterodine tartrate profile page.
Summary for 213397
| Tradename: | TOLTERODINE TARTRATE |
| Applicant: | Ajanta Pharma Ltd |
| Ingredient: | tolterodine tartrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213397
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 213397
Suppliers and Packaging for NDA: 213397
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOLTERODINE TARTRATE | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 213397 | ANDA | Ajanta Pharma USA Inc. | 27241-191 | 27241-191-05 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-191-05) |
| TOLTERODINE TARTRATE | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 213397 | ANDA | Ajanta Pharma USA Inc. | 27241-191 | 27241-191-30 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-191-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 2MG | ||||
| Approval Date: | May 19, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 4MG | ||||
| Approval Date: | May 19, 2020 | TE: | AB | RLD: | No | ||||
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