Details for New Drug Application (NDA): 021228
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NDA 021228 describes DETROL LA, which is a drug marketed by Upjohn and is included in one NDA. It is available from three suppliers. Additional details are available on the DETROL LA profile page.
The generic ingredient in DETROL LA 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 DETROL LA 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 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 | Pharmacia and Upjohn Company LLC | 0009-5190 | 0009-5190-01 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0009-5190-01) |
| DETROL LA | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 021228 | NDA | Pharmacia and Upjohn Company LLC | 0009-5190 | 0009-5190-02 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0009-5190-02) |
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 | 021228-001 | Dec 22, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Upjohn | DETROL LA | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 021228-001 | Dec 22, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Upjohn | DETROL LA | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 021228-002 | Dec 22, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Upjohn | DETROL LA | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 021228-002 | Dec 22, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Upjohn | DETROL LA | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 021228-002 | Dec 22, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Upjohn | DETROL LA | tolterodine tartrate | CAPSULE, EXTENDED RELEASE;ORAL | 021228-001 | Dec 22, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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