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Generated: April 21, 2019

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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. It is available from one supplier. 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. Eighty-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
Suppliers and Packaging for NDA: 020711
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711 NDA GlaxoSmithKline LLC 0173-0556 0173-0556-01 60 TABLET, FILM COATED in 1 BOTTLE (0173-0556-01)

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:May 14, 1997TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:May 14, 1997TE:AB2RLD: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 Free Trial ➤ Try a Free Trial
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-002 May 14, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-002 May 14, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-002 May 14, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-003 May 14, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-003 May 14, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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