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. Forty 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 |
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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