Details for New Drug Application (NDA): 020711
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The generic ingredient in ZYBAN is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.
Summary for 020711
Tradename: | ZYBAN |
Applicant: | Glaxosmithkline |
Ingredient: | bupropion hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | May 14, 1997 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | May 14, 1997 | TE: | RLD: | Yes |
Expired US Patents for NDA 020711
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline | ZYBAN | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020711-002 | May 14, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | ZYBAN | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020711-002 | May 14, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | ZYBAN | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020711-002 | May 14, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | ZYBAN | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020711-002 | May 14, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
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