Details for New Drug Application (NDA): 215430
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The generic ingredient in AUVELITY is bupropion hydrochloride; dextromethorphan hydrobromide. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bupropion hydrochloride; dextromethorphan hydrobromide profile page.
Summary for 215430
Tradename: | AUVELITY |
Applicant: | Axsome |
Ingredient: | bupropion hydrochloride; dextromethorphan hydrobromide |
Patents: | 119 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215430
Generic Entry Date for 215430*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 215430
Suppliers and Packaging for NDA: 215430
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AUVELITY | bupropion hydrochloride; dextromethorphan hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 215430 | NDA | Axsome Therapeutics, Inc. | 81968-045 | 81968-045-14 | 1 BOTTLE in 1 CARTON (81968-045-14) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE |
AUVELITY | bupropion hydrochloride; dextromethorphan hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 215430 | NDA | Axsome Therapeutics, Inc. | 81968-045 | 81968-045-30 | 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 105MG;45MG | ||||
Approval Date: | Aug 18, 2022 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Aug 18, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 5, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 5, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER |
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