Details for New Drug Application (NDA): 204562
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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 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 | ANI Pharmaceuticals, Inc. | 43975-322 | 43975-322-03 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-322-03) |
TOLTERODINE TARTRATE | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 204562 | ANDA | ANI Pharmaceuticals, Inc. | 43975-322 | 43975-322-09 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-322-09) |
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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