Viewing data from:

BUPROPION HYDROCHLORIDE

ANDA

BUPROPION HYDROCHLORIDE | A075913 | IMPAX LABORATORIES INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: WELLBUTRIN SR(TE code: AB1)

API Supply Chain25 active DMFs13 inactive

22 active API suppliers hold Drug Master Files for this ingredient.

ERREGIERRE SPABUPROPION HYDROCHLORIDE USP

DMF 110541994

CHEMI SPABUPROPION HYDROCHLORIDE

DMF 118341996

OLON SPABUPROPION HYDROCHLORIDE

DMF 139271998

HIKAL LTDBUPROPION HYDROCHLORIDE USP

DMF 164762003

OLON SPABUPROPION HYDROCHLORIDE

DMF 177842004

ALIVUS LIFE SCIENCES LTDBUPROPION HYDROCHLORIDE USP

DMF 181632005

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDBUPROPION HYDROCHLORIDE USP

DMF 182002005

DIVIS LABORATORIES LTDBUPROPION HYDROCHLORIDE USP

DMF 183062005

APITORIA PHARMA PRIVATE LTDBUPROPION HYDROCHLORIDE USP

DMF 191532006

JUBILANT BIOSYS LTDBUPROPION HYDROCHLORIDE USP

DMF 198352006

SUN PHARMACEUTICAL INDUSTRIES LTDBUPROPION HYDROCHLORIDE USP

DMF 202102007

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDBUPROPION HYDROCHLORIDE USP

DMF 212222007

ALEMBIC PHARMACEUTICALS LTDBUPROPION HYDROCHLORIDE USP

DMF 220642008

AARTI PHARMALABS LTDBUPROPION HYDROCHLORIDE

DMF 272042013

HETERO DRUGS LTDBUPROPION HYDROCHLORIDE (PROCESS-II)

DMF 282972014

HIKAL LTDBUPROPION HYDROCHLORIDE USP [PROCESS-2]

DMF 284212014

CADILA PHARMACEUTICALS LTDBUPROPION HYDROCHLORIDE USP

DMF 285742014

ZYDUS LIFESCIENCES LTDBUPROPION HYDROCHLORIDE USP (PROCESS-II)

DMF 322482017

ZHEJIANG SHAXING TECHNOLOGY CO LTDBUPROPION HYDROCHLORIDE

DMF 342852019

CHEMECA DRUGS PRIVATE LTDBUPROPION HYDROCHLORIDE USP

DMF 354182020

GRANULES INDIA LTDBUPROPION HYDROCHLORIDE USP

DMF 356942021

SUN PHARMACEUTICAL INDUSTRIES LTDBUPROPION HYDROCHLORIDE USP (PROCESS-II)

DMF 394142024

EMNAR PHARMA PRIVATE LTDBUPROPION HYDROCHLORIDE

DMF 400882024

IPCA LABORATORIES LTDBUPROPION HYDROCHLORIDE USP

DMF 401462024

ZHEJIANG SYNCOZYMES BIO-PHARMACEUTICAL CO LTDBUPROPION HYDROCHLORIDE

DMF 420522025

NORDIC SYNTHESIS ABInactiveBUPROPION HYDROCHLORIDE

DMF 111961994

CILAG AGInactiveBUPROPION HYDROCHLORIDE

DMF 120891996

SOLMAG SPAInactiveBUPROPION HYDROCHLORIDE

DMF 138511998

SEVEN STAR PHARMACEUTICAL CO LTDInactiveBUPROPION HYDROCHLORIDE USP

DMF 177892004

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveBUPROPION HYDROCHLORIDE USP

DMF 179252004

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDInactiveBUPROPION HYDROCHLORIDE USP

DMF 181232005

PHARMACEUTICAL WORKS POLPHARMA SAInactiveBUPROPION HYDROCHLORIDE

DMF 181272005

CADILA HEALTHCARE LTDInactiveBUPROPION HYDROCHLORIDE

DMF 192972006

HANZHONG HANJIANG VENTUREPHARM PHARMACEUTICAL LTDInactiveBUPROPION HYDROCHLORIDE

DMF 194202006

ZHEJIANG XINHUA PHARMACEUTICAL CO LTDInactiveBUPROPION HYDROCHLORIDE

DMF 200852006

DERIVADOS QUIMICOS SAUInactiveBUPROPION HYDROCHLORIDE

DMF 237422010

HETERO DRUGS LTDInactiveBUPROPION HYDROCHLORIDE

DMF 267522012

LUPIN LTDInactiveBUPROPION HYDROCHLORIDE USP

DMF 335112019

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 24, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG

AB1

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jan 28, 2004

No patent or exclusivity listings for this strength.

#002 — 150MG

AB1

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Mar 22, 2004