Details for New Drug Application (NDA): 074625
✉ Email this page to a colleague
The generic ingredient in OXYBUTYNIN CHLORIDE is oxybutynin chloride. There are sixteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.
Summary for 074625
Tradename: | OXYBUTYNIN CHLORIDE |
Applicant: | Upsher Smith Labs |
Ingredient: | oxybutynin chloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074625
Mechanism of Action | Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 074625
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 074625 | ANDA | Upsher-Smith Laboratories, LLC | 0832-0038 | 0832-0038-00 | 100 TABLET in 1 BOTTLE (0832-0038-00) |
OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 074625 | ANDA | Upsher-Smith Laboratories, LLC | 0832-0038 | 0832-0038-01 | 100 BLISTER PACK in 1 CARTON (0832-0038-01) / 1 TABLET in 1 BLISTER PACK (0832-0038-89) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jul 31, 1996 | TE: | AB | RLD: | No |
Complete Access Available with Subscription