Details for New Drug Application (NDA): 022108
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The generic ingredient in APLENZIN is bupropion 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 hydrobromide profile page.
Summary for 022108
Tradename: | APLENZIN |
Applicant: | Bausch |
Ingredient: | bupropion hydrobromide |
Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022108
Generic Entry Date for 022108*:
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: 022108
Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Suppliers and Packaging for NDA: 022108
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108 | NDA | Bausch Health US, LLC | 0187-5810 | 0187-5810-07 | 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5810-07) |
APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108 | NDA | Bausch Health US, LLC | 0187-5810 | 0187-5810-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5810-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 174MG | ||||
Approval Date: | Apr 23, 2008 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 27, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 27, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF MAJOR DEPRESSIVE DISORDER BY DOSING AT INTERVALS OF 24 HOURS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 27, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? |
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