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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

BUPROPION HYDROBROMIDE

ANDA

Tentative Approval

BUPROPION HYDROBROMIDE | A200835 | WATSON LABS INC

API Supply Chain8 active DMFs3 inactive

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

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDBUPROPION HYDROBROMIDE

DMF 252542011

JUBILANT PHARMOVA LTDBUPROPION HYDROBROMIDE

DMF 267202013

HIKAL LTDBUPROPION HYDROBROMIDE (FORM-I)

DMF 382312023

HIKAL LTDBUPROPION HYDROBROMIDE (FORM II)

DMF 383842023

LUPIN MANUFACTURING SOLUTIONS LTDBUPROPION HYDROBROMIDE

DMF 392242023

HETERO DRUGS LTDBUPROPION HYDROBROMIDE

DMF 405832024

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDBUPROPION HYDROBROMIDE

DMF 409322024

ALIVUS LIFE SCIENCES LTDBUPROPION HYDROBROMIDE

DMF 416012025

ERREGIERRE SPAInactiveBUPROPION HYDROBROMIDE

DMF 224192009

DIPHARMA FRANCIS SRLInactiveBUPROPION HYDROBROMIDE

DMF 227202009

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDInactiveBUPROPION HYDROBROMIDE API

DMF 228092009

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

Products (2)

Sort:

#001 — 174MG

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TABLET, EXTENDED RELEASE; ORAL | TA Date: 2013-08-13 00:00:00

No patent or exclusivity listings for this strength.

#002 — 522MG

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TABLET, EXTENDED RELEASE; ORAL | TA Date: 2013-08-13 00:00:00