Details for New Drug Application (NDA): 203409
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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 203409
Tradename: | TOLTERODINE TARTRATE |
Applicant: | Macleods Pharms Ltd |
Ingredient: | tolterodine tartrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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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