Details for New Drug Application (NDA): 076835
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NDA 076835 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 076835
| Tradename: | FLAVOXATE HYDROCHLORIDE |
| Applicant: | Epic Pharma |
| Ingredient: | flavoxate hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 076835
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 076835
Suppliers and Packaging for NDA: 076835
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLAVOXATE HYDROCHLORIDE | flavoxate hydrochloride | TABLET;ORAL | 076835 | ANDA | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 24658-720 | 24658-720-01 | 100 TABLET in 1 BOTTLE (24658-720-01) |
| FLAVOXATE HYDROCHLORIDE | flavoxate hydrochloride | TABLET;ORAL | 076835 | ANDA | Epic Pharma, LLC | 42806-058 | 42806-058-01 | 100 TABLET in 1 BOTTLE (42806-058-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Nov 30, 2005 | TE: | AB | RLD: | No | ||||
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