Details for New Drug Application (NDA): 208165
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The generic ingredient in OXYBUTYNIN CHLORIDE is oxybutynin chloride. There are sixteen drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.
Summary for 208165
Tradename: | OXYBUTYNIN CHLORIDE |
Applicant: | Strides Pharma |
Ingredient: | oxybutynin chloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208165
Mechanism of Action | Cholinergic Muscarinic Antagonists |
Suppliers and Packaging for NDA: 208165
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 208165 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-810 | 23155-810-01 | 100 TABLET in 1 BOTTLE (23155-810-01) |
OXYBUTYNIN CHLORIDE | oxybutynin chloride | TABLET;ORAL | 208165 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-810 | 23155-810-05 | 500 TABLET in 1 BOTTLE (23155-810-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 17, 2020 | TE: | AB | RLD: | No |
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