FDA.reportPublic FDA data

Application 021306

Type
NDA
Sponsor
PURDUE PHARMA LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTRANSBUPRENORPHINEFILM, EXTENDED RELEASE;TRANSDERMAL5MCG/HRYesNo
002BUTRANSBUPRENORPHINEFILM, EXTENDED RELEASE;TRANSDERMAL10MCG/HRYesNo
003BUTRANSBUPRENORPHINEFILM, EXTENDED RELEASE;TRANSDERMAL20MCG/HRYesYes
004BUTRANSBUPRENORPHINEFILM, EXTENDED RELEASE;TRANSDERMAL15MCG/HRYesNo
005BUTRANSBUPRENORPHINEFILM, EXTENDED RELEASE;TRANSDERMAL7.5MCG/HRYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3600BuprenorphineBuprenorphineTeva Pharmaceuticals USA,NDA AUTHORIZED Current
0093-3601BuprenorphineBuprenorphineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3602BuprenorphineBuprenorphineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3603BuprenorphineBuprenorphineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
42858-353BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-353BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-353BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-353BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-353BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-493BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-493BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-493BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-493BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-493BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-586BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-586BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-586BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-586BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-586BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-750BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-750BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-750BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-750BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-750BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-839BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-839BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-839BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-839BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
42858-839BuprenorphineBuprenorphineRhodes Pharmaceuticals L.P.NDA AUTHORIZED GENERICCurrent
55700-568BuprenorphineBuprenorphineLake Erie Medical DBA Quality Care Products LLCNDA AUTHORIZED GENERICCurrent
55700-579BuprenorphineBuprenorphineLake Erie Medical DBA Quality Care Products LLCNDA AUTHORIZED GENERICCurrent
55700-579BuprenorphineBuprenorphineLake Erie Medical DBA Quality Care Products LLCNDA AUTHORIZED GENERICCurrent
59011-750ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-750ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-750ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-750ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-750ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-750ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-751ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-751ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-751ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-751ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-751ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-751ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-752ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-752ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-752ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-752ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-752ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-752ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-757ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-757ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-757ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-757ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-757ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-757ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-758ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-758ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-758ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-758ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-758ButransbuprenorphinePurdue Pharma LPNDACurrent
59011-758ButransbuprenorphinePurdue Pharma LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84684SUPPL 2026-01-06
84601SUPPL 2025-12-31
80095SUPPL 2024-11-04
77002SUPPL 2023-12-19
76905SUPPL 2023-12-18
76904SUPPL 2023-12-18
71410SUPPL2022-06-21
71409SUPPL2022-06-21
71368SUPPL2022-06-21
66595SUPPL2021-03-08
66594SUPPL2021-03-08
66549SUPPL2021-03-05
60347SUPPL2019-10-08
60337SUPPL2019-10-08
60336SUPPL2019-10-08
55983SUPPL2018-10-17
55982SUPPL2018-10-17
55681SUPPL2018-10-01
55680SUPPL2018-10-01
50081SUPPL2017-10-18
50073SUPPL2017-10-18
49487SUPPL2017-08-21
48591SUPPL2017-05-31
46356SUPPL2016-12-21
46280SUPPL2016-12-20
45464SUPPL2016-10-04
27443SUPPL2016-04-22
27442SUPPL2015-07-06
4991SUPPL2014-08-20
36630SUPPL2014-07-02
15158SUPPL2014-07-02
27440SUPPL2014-07-01
4990SUPPL2014-07-01
4989SUPPL2014-04-17
15160SUPPL2014-04-16
15159SUPPL2013-07-30
27441SUPPL2013-07-29
27439SUPPL2013-04-16
36629SUPPL2012-07-12
27438SUPPL2012-07-11
44640ORIG2011-09-26
42091ORIG2011-09-26
27437SUPPL2011-07-07
27436SUPPL2011-07-07
36628SUPPL2011-07-06
15157SUPPL2011-07-06
23992ORIG2010-08-05
15156ORIG2010-07-06
27435ORIG2010-07-02
52071SUPPL1900-01-01
52070SUPPL1900-01-01