Details for New Drug Application (NDA): 075079
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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 075079
Tradename: | OXYBUTYNIN CHLORIDE |
Applicant: | Strides Pharma |
Ingredient: | oxybutynin chloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075079
Mechanism of Action | Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 075079
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 075079 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-3512 | 0615-3512-39 | 30 TABLET in 1 BLISTER PACK (0615-3512-39) |
OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 075079 | ANDA | AvKARE | 42291-914 | 42291-914-50 | 500 TABLET in 1 BOTTLE (42291-914-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Oct 31, 1997 | TE: | AB | RLD: | No |
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