Details for New Drug Application (NDA): 022108
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NDA 022108 describes APLENZIN, which is a drug marketed by Bausch and is included in one NDA. It is available from two suppliers. There are eight patents protecting this drug and three Paragraph IV challenges. Additional details are available on the APLENZIN profile page.
The generic ingredient in APLENZIN is bupropion hydrobromide. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the bupropion hydrobromide profile page.
The generic ingredient in APLENZIN is bupropion hydrobromide. There is one drug master file entry for this compound. Two suppliers are 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 |
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: | ⤷ Start Trial | Patent Expiration: | Jun 27, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | 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: | ⤷ Start Trial | Patent Expiration: | Jun 27, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 022108
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-003 | Apr 23, 2008 | ⤷ Start Trial | ⤷ Start Trial |
| Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-001 | Apr 23, 2008 | ⤷ Start Trial | ⤷ Start Trial |
| Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-002 | Apr 23, 2008 | ⤷ Start Trial | ⤷ Start Trial |
| Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-002 | Apr 23, 2008 | ⤷ Start Trial | ⤷ Start Trial |
| Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-001 | Apr 23, 2008 | ⤷ Start Trial | ⤷ Start Trial |
| Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-002 | Apr 23, 2008 | ⤷ Start Trial | ⤷ Start Trial |
| Bausch | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-003 | Apr 23, 2008 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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