Details for New Drug Application (NDA): 077006
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NDA 077006 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 Ltd, Pharmobedient, Pts Consulting, and Rising, and is included in sixteen NDAs. It is available from fifteen 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. Eighteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the tolterodine tartrate profile page.
Summary for 077006
| Tradename: | TOLTERODINE TARTRATE |
| Applicant: | Ivax Sub Teva Pharms |
| Ingredient: | tolterodine tartrate |
| Patents: | 0 |
Pharmacology for NDA: 077006
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 077006
Suppliers and Packaging for NDA: 077006
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOLTERODINE TARTRATE | tolterodine tartrate | TABLET;ORAL | 077006 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-0010 | 0093-0010-06 | 60 TABLET, FILM COATED in 1 BOTTLE (0093-0010-06) |
| TOLTERODINE TARTRATE | tolterodine tartrate | TABLET;ORAL | 077006 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-0018 | 0093-0018-05 | 500 TABLET, FILM COATED in 1 BOTTLE (0093-0018-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Feb 23, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Feb 23, 2015 | TE: | AB | RLD: | No | ||||
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