Details for New Drug Application (NDA): 076831
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NDA 076831 describes FLAVOXATE HYDROCHLORIDE, which is a drug marketed by Epic Pharma, Impax Pharms, and Padagis Us, and is included in three NDAs. It is available from three suppliers. Additional details are available on the FLAVOXATE HYDROCHLORIDE profile page.
The generic ingredient in FLAVOXATE HYDROCHLORIDE is flavoxate hydrochloride. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the flavoxate hydrochloride profile page.
The generic ingredient in FLAVOXATE HYDROCHLORIDE is flavoxate hydrochloride. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the flavoxate hydrochloride profile page.
Summary for 076831
| Tradename: | FLAVOXATE HYDROCHLORIDE |
| Applicant: | Padagis Us |
| Ingredient: | flavoxate hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 076831
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 076831
Suppliers and Packaging for NDA: 076831
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLAVOXATE HYDROCHLORIDE | flavoxate hydrochloride | TABLET;ORAL | 076831 | ANDA | Padagis US LLC | 0574-0115 | 0574-0115-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0574-0115-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Dec 16, 2004 | TE: | AB | RLD: | No | ||||
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