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.
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDATentative Approval
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | A214737 | SUN PHARM INDUSTRIES
Products (6)
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#001 — EQ 1.4MG BASE;EQ 0.36MG BASE
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TABLET;SUBLINGUAL | TA Date: 2023-08-11 00:00:00
No patent or exclusivity listings for this strength.