Details for New Drug Application (NDA): 210125
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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 210125
Tradename: | OXYBUTYNIN CHLORIDE |
Applicant: | Tulex Pharms Inc |
Ingredient: | oxybutynin chloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210125
Mechanism of Action | Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 210125
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 210125 | ANDA | TruPharma LLC | 52817-260 | 52817-260-10 | 100 TABLET in 1 BOTTLE, PLASTIC (52817-260-10) |
OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 210125 | ANDA | TruPharma LLC | 52817-260 | 52817-260-50 | 500 TABLET in 1 BOTTLE, PLASTIC (52817-260-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Sep 6, 2018 | TE: | AB | RLD: | No |
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