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Generated: September 23, 2017

DrugPatentWatch Database Preview

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-seven drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

Summary for NDA: 020711

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antidepressants
Antidotes, Deterrents, and Toxicologic Agents
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)

Summary for product number 002

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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength150MG
Approval Date:May 14, 1997TE:AB2RLD:Yes

Expired Orange Book Patents for NDA: 020711

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
ZYBAN
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL020711-002May 14, 1997► Subscribe► Subscribe
Glaxosmithkline
ZYBAN
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL020711-002May 14, 1997► Subscribe► Subscribe
Glaxosmithkline
ZYBAN
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL020711-002May 14, 1997► Subscribe► Subscribe
Glaxosmithkline
ZYBAN
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL020711-002May 14, 1997► Subscribe► Subscribe
Glaxosmithkline
ZYBAN
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL020711-003May 14, 1997► Subscribe► Subscribe
Glaxosmithkline
ZYBAN
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL020711-003May 14, 1997► Subscribe► Subscribe
Glaxosmithkline
ZYBAN
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL020711-003May 14, 1997► Subscribe► Subscribe
Glaxosmithkline
ZYBAN
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL020711-002May 14, 1997► Subscribe► Subscribe
Glaxosmithkline
ZYBAN
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL020711-003May 14, 1997► Subscribe► Subscribe
Glaxosmithkline
ZYBAN
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL020711-003May 14, 1997► Subscribe► Subscribe
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