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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.

ELETRIPTAN HYDROBROMIDE

ANDA

Tentative Approval

ELETRIPTAN HYDROBROMIDE | A201536 | APOTEX INC

API Supply Chain10 active DMFs2 inactive

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

TAPI NL BVELETRIPTAN HYDROBROMIDE

DMF 229122009

MATRIX PHARMACORP PRIVATE LTDELETRIPTAN HYDROBROMIDE (PROCESS 1)

DMF 245042010

FIS FABBRICA ITALIANA SINTETICI SPAELETRIPTAN HYDROBROMIDE

DMF 245282010

SMS PHARMACEUTICALS LTDELETRIPTAN HYDROBROMIDE MONOHYDRATE

DMF 249052011

MATRIX PHARMACORP PRIVATE LTDELETRIPTAN HYDROBROMIDE (PROCESS 2)

DMF 250762011

HETERO DRUGS LTDELETRIPTAN HYDROBROMIDE

DMF 260992012

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTDELETRIPTAN HYDROBROMIDE "YUNG SHIN"

DMF 296162015

TIANJIN WEIJIE PHARMACEUTICAL CO LTDELETRIPTAN HYDROBROMIDE

DMF 303382016

APITORIA PHARMA PRIVATE LTDELETRIPTAN HYDROBROMIDE

DMF 313362017

SMS PHARMACEUTICALS LTDELETRIPTAN HYDROBROMIDE

DMF 421282025

APOTEX PHARMACHEM INDIA PVT LTDInactiveELETRIPTAN HYDROBROMIDE

DMF 236512010

VIWIT PHARMACEUTICAL CO LTDInactiveELETRIPTAN HYDROBROMIDE (DRUG SUBSTANCE, NON-STERILE)

DMF 270692013

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

Products (2)

Sort:

#001 — 20MG

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TABLET; ORAL | TA Date: 2013-07-29 00:00:00

No patent or exclusivity listings for this strength.

#002 — 40MG

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TABLET; ORAL | TA Date: 2013-07-29 00:00:00