Details for New Drug Application (NDA): 074520
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The generic ingredient in OXYBUTYNIN CHLORIDE is oxybutynin chloride. There are sixteen drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.
Summary for 074520
Tradename: | OXYBUTYNIN CHLORIDE |
Applicant: | Lannett Co Inc |
Ingredient: | oxybutynin chloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074520
Mechanism of Action | Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 074520
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | oxybutynin chloride | SYRUP;ORAL | 074520 | ANDA | Lannett Company, Inc. | 54838-510 | 54838-510-80 | 473 mL in 1 BOTTLE, PLASTIC (54838-510-80) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | Mar 29, 1996 | TE: | AA | RLD: | No |
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