Details for New Drug Application (NDA): 210717
✉ Email this page to a colleague
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 210717
Tradename: | OXYBUTYNIN CHLORIDE |
Applicant: | Bionpharma |
Ingredient: | oxybutynin chloride |
Patents: | 0 |
Pharmacology for NDA: 210717
Mechanism of Action | Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 210717
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 210717 | ANDA | Bionpharma Inc. | 69452-119 | 69452-119-20 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69452-119-20) |
OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET, EXTENDED RELEASE;ORAL | 210717 | ANDA | Bionpharma Inc. | 69452-120 | 69452-120-20 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69452-120-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 17, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 17, 2019 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 15MG | ||||
Approval Date: | Dec 17, 2019 | TE: | AB | RLD: | No |
Complete Access Available with Subscription