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.
AMLODIPINE BESYLATE
ANDATentative Approval
AMLODIPINE BESYLATE | A210489 | IPCA LABS LTD
Products (3)
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#001 — EQ 2.5MG BASE
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TABLET;ORAL | Approved: 2026-09-22 00:00:00
No patent or exclusivity listings for this strength.