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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.

TELMISARTAN; HYDROCHLOROTHIAZIDE

ANDA

Tentative Approval

TELMISARTAN; HYDROCHLOROTHIAZIDE | A091084 | WATSON LABS FLORIDA

Products (3)

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#001 — 40MG; 12.5MG

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TABLET; ORAL | TA Date: 2011-09-15 00:00:00

No patent or exclusivity listings for this strength.

#002 — 80MG; 12.5MG

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TABLET; ORAL | TA Date: 2011-09-15 00:00:00

#003 — 80MG; 25MG

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TABLET; ORAL | TA Date: 2011-09-15 00:00:00