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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.

TESTOSTERONE UNDECANOATE

ANDATentative Approval

TESTOSTERONE UNDECANOATE | A207583 | HIKMA PHARMACEUTICALS USA INC

API Supply Chain7 active DMFs

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

ASPEN OSS BVTESTOSTERONE UNDECANOATE

DMF 145401999

BAYER AGTESTOSTERONE UNDECANOATE

DMF 167952003

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDTESTOSTERONE UNDECANOATE, NON-STERILE, BULK DRUG SUBSTANCE

DMF 239342010

PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INCTESTOSTERONE UNDECANOATE

DMF 245002011

SYMBIOTEC PHARMALAB PRIVATE LTDTESTOSTERONE UNDECANOATE

DMF 255342011

STEROID SPATESTOSTERONE UNDECANOATE

DMF 275312013

HUBEI ZHUXI HUMANWELL PHARMACEUTICAL CO LTDTESTOSTERONE UNDECANOATE

DMF 401202024

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

Products (1)

#001 — 750MG/3ML (250MG/ML)

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INJECTABLE;INTRAMUSCULAR | TA Date: Dec. 9, 2016

No patent or exclusivity listings for this strength.