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. Forty 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 |
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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