Details for New Drug Application (NDA): 021228
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The generic ingredient in DETROL LA 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 021228
| Tradename: | DETROL LA |
| Applicant: | Upjohn |
| Ingredient: | tolterodine tartrate |
| Patents: | 0 |
Pharmacology for NDA: 021228
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 021228
Suppliers and Packaging for NDA: 021228
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DETROL LA | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 021228 | NDA | Viatris Specialty LLC | 58151-103 | 58151-103-77 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-103-77) |
| DETROL LA | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 021228 | NDA | Viatris Specialty LLC | 58151-103 | 58151-103-93 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-103-93) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 2MG | ||||
| Approval Date: | Dec 22, 2000 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 4MG | ||||
| Approval Date: | Dec 22, 2000 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021228
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Upjohn | DETROL LA | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 021228-002 | Dec 22, 2000 | 5,559,269*PED | ⤷ Get Started Free |
| Upjohn | DETROL LA | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 021228-001 | Dec 22, 2000 | 5,382,600*PED | ⤷ Get Started Free |
| Upjohn | DETROL LA | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 021228-002 | Dec 22, 2000 | 6,630,162*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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