Details for New Drug Application (NDA): 074625
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The generic ingredient in OXYBUTYNIN CHLORIDE is oxybutynin chloride. There are sixteen drug master file entries for this compound. Thirty-nine 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 |
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