Details for New Drug Application (NDA): 209335
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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 209335
Tradename: | OXYBUTYNIN CHLORIDE |
Applicant: | Abhai Llc |
Ingredient: | oxybutynin chloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209335
Mechanism of Action | Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 209335
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 209335 | ANDA | KVK-Tech, Inc. | 10702-201 | 10702-201-01 | 100 TABLET in 1 BOTTLE, PLASTIC (10702-201-01) |
OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 209335 | ANDA | KVK-Tech, Inc. | 10702-201 | 10702-201-10 | 1000 TABLET in 1 BOTTLE, PLASTIC (10702-201-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 22, 2017 | TE: | AB | RLD: | No |
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