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.
IRBESARTAN; HYDROCHLOROTHIAZIDE
ANDATentative Approval
IRBESARTAN; HYDROCHLOROTHIAZIDE | A090815 | ZYDUS PHARMS USA INC
Products (3)
Sort:
#001 — 150MG; 12.5MG
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TABLET; ORAL | TA Date: 2011-02-16 00:00:00
No patent or exclusivity listings for this strength.