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`Drug Details
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`Drug Name(s)
`
`FDA Application No.
`
`Active Ingredient(s)
`
`Company
`
`SUBOXONE
`
`(NDA) 020733
`
`BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
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`RECKITT BENCKISER
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`Original Approval or Tentative Approval Date October 8, 2002
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`Chemical Type
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`Review Classification
`
`4 New combination
`
`P Priority review drug
`O Orphan drug
`
`(cid:1) There are no Therapeutic Equivalents
`
`(cid:1) Label Information
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`(cid:1) Approval History, Letters, Reviews, and
`Related Documents
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`(cid:1) REMS10
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`(cid:1) Other Important Information from FDA 11
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`(cid:1) Medication Guide12
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`Products on Application (NDA) #020733
` Click on a column header to re-sort the table:
`
`Active Ingredients
`
`Drug
`Name
`SUBOXONE BUPRENORPHINE HYDROCHLORIDE;
`NALOXONE HYDROCHLORIDE
`SUBOXONE BUPRENORPHINE HYDROCHLORIDE;
`NALOXONE HYDROCHLORIDE
`
`Strength
`
`EQ 2MG BASE; EQ
`0.5MG BASE
`EQ 8MG BASE; EQ
`2MG BASE
`
`RLDTE
`Marketing
`Dosage
`Code
`Status
`Form/Route
`TABLET;SUBLINGUAL Discontinued No None
`
`TABLET;SUBLINGUAL Discontinued No None
`
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