Details for New Drug Application (NDA): 020711
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NDA 020711 describes ZYBAN, which is a drug marketed by Glaxosmithkline and is included in one NDA. Additional details are available on the ZYBAN profile page.
The generic ingredient in ZYBAN is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.
The generic ingredient in ZYBAN is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Seventy-six 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 |
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TABLET, EXTENDED RELEASE;ORAL | Strength | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | ZYBAN | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020711-002 | May 14, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | ZYBAN | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020711-003 | May 14, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | ZYBAN | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020711-003 | May 14, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | ZYBAN | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020711-003 | May 14, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | ZYBAN | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020711-002 | May 14, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | ZYBAN | bupropion hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 020711-003 | May 14, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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