Details for New Drug Application (NDA): 075039
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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 075039
Tradename: | OXYBUTYNIN CHLORIDE |
Applicant: | Chartwell Rx |
Ingredient: | oxybutynin chloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075039
Mechanism of Action | Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 075039
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | oxybutynin chloride | SYRUP;ORAL | 075039 | ANDA | Chartwell RX, LLC | 62135-520 | 62135-520-47 | 473 mL in 1 BOTTLE (62135-520-47) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Jan 29, 1999 | TE: | AA | RLD: | No |
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