Details for New Drug Application (NDA): 078503
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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 078503
Tradename: | OXYBUTYNIN CHLORIDE |
Applicant: | Osmotica Pharm Us |
Ingredient: | oxybutynin chloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078503
Mechanism of Action | Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 078503
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 078503 | ANDA | AvKARE | 42291-633 | 42291-633-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-633-01) |
OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 078503 | ANDA | AvKARE | 42291-633 | 42291-633-50 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-633-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
Approval Date: | Feb 4, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
Approval Date: | Feb 4, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
Approval Date: | Feb 4, 2009 | TE: | AB | RLD: | No |
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