FDA.reportPublic FDA data

Application 021205

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIZIVIRABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINETABLET;ORALEQ 300MG BASE;150MG;300MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021205-001TRIZIVIRABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINEEQ 300MG BASE;150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-11-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021205-001TRIZIVIREQ 300MG BASE;150MG;300MGTABLET / ORALABRLD, RS2000-11-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021205-001TRIZIVIREQ 300MG BASE;150MG;300MGTABLET / ORALABRLD, RS2000-11-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021205-001TRIZIVIREQ 300MG BASE;150MG;300MGTABLET / ORALABRLD, RS2000-11-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021205-001TRIZIVIREQ 300MG BASE;150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2000-11-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021205-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021205-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021205-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021205-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021205-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021205-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021205-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021205-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021205-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021205-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021205-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021205-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021205-001AB1ea99ee380514…
2023-12-20 04:57 UTC2023-12N021205-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021205-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021205-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021205-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021205-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021205-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021205-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021205-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021205-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021205-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021205-001AB1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49702-217TRIZIVIRabacavir sulfate, lamivudine, and zidovudineViiV Healthcare CompanyNDACurrent
49702-217TRIZIVIRabacavir sulfate, lamivudine, and zidovudineViiV Healthcare CompanyNDACurrent
49702-217TRIZIVIRabacavir sulfate, lamivudine, and zidovudineViiV Healthcare CompanyNDACurrent
49702-217TRIZIVIRabacavir sulfate, lamivudine, and zidovudineViiV Healthcare CompanyNDACurrent
49702-217TRIZIVIRabacavir sulfate, lamivudine, and zidovudineViiV Healthcare CompanyNDACurrent
49702-217TRIZIVIRabacavir sulfate, lamivudine, and zidovudineViiV Healthcare CompanyNDACurrent
53808-0990TRIZIVIRabacavir sulfate, lamivudine, and zidovudineState of Florida DOH Central PharmacyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66293SUPPL2021-02-18
66284SUPPL2021-02-18
58710SUPPL2019-05-15
58709SUPPL2019-05-15
58695SUPPL2019-05-14
54871SUPPL2018-07-12
53985SUPPL2018-05-03
48059SUPPL2017-04-18
47600SUPPL2017-03-20
47437SUPPL2017-03-03
47367SUPPL2017-02-28
36354SUPPL2015-10-07
4639SUPPL2015-10-02
36353SUPPL2012-05-22
4638SUPPL2012-05-22
27066SUPPL2012-03-13
36352SUPPL2012-03-12
36351SUPPL2011-11-25
27065SUPPL2011-11-22
27064SUPPL2011-05-17
4637SUPPL2011-04-04
36350SUPPL2011-04-01
27063SUPPL2010-08-10
14632SUPPL2009-04-03
4636SUPPL2009-03-11
42029SUPPL2007-07-09
42028SUPPL2007-07-09
42027SUPPL2007-07-09
42026SUPPL2007-07-09
42025SUPPL2007-07-09
42024SUPPL2007-07-09
36349SUPPL2007-05-09
27062SUPPL2007-05-09
4635SUPPL2006-08-18
36348SUPPL2006-08-14
36347SUPPL2005-05-17
27061SUPPL2005-05-17
42022SUPPL2005-04-08
42023SUPPL2005-03-08
21506SUPPL2005-03-08
36343ORIG2004-06-28
27058ORIG2004-06-28
42021ORIG2004-03-28
27059SUPPL2004-03-01
4633SUPPL2004-03-01
36346SUPPL2002-10-08
27060SUPPL2002-10-08
36345SUPPL2002-08-13
4634SUPPL2002-08-13
36344SUPPL2002-06-04
4632SUPPL2002-02-05