Application 021356

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIREADTENOFOVIR DISOPROXIL FUMARATETABLET;ORAL300MGYesYes
002VIREADTENOFOVIR DISOPROXIL FUMARATETABLET;ORAL150MGYesNo
003VIREADTENOFOVIR DISOPROXIL FUMARATETABLET;ORAL200MGYesNo
004VIREADTENOFOVIR DISOPROXIL FUMARATETABLET;ORAL250MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021356-001VIREADTENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALABRLD, RS2001-10-26
N021356-002VIREADTENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALABRLD2012-01-18
N021356-003VIREADTENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALABRLD2012-01-18
N021356-004VIREADTENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALABRLD2012-01-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N021356-001AB
N021356-002AB
N021356-003AB
N021356-004AB

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 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021356-001VIREAD300MGTABLET / ORALABRLD, RS2001-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021356-002VIREAD150MGTABLET / ORALABRLD2012-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021356-003VIREAD200MGTABLET / ORALABRLD2012-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021356-004VIREAD250MGTABLET / ORALABRLD2012-01-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021356-001VIREAD300MGTABLET / ORALABRLD, RS2001-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021356-002VIREAD150MGTABLET / ORALABRLD2012-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021356-003VIREAD200MGTABLET / ORALABRLD2012-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021356-004VIREAD250MGTABLET / ORALABRLD2012-01-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021356-001VIREAD300MGTABLET / ORALABRLD, RS2001-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021356-002VIREAD150MGTABLET / ORALABRLD2012-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021356-003VIREAD200MGTABLET / ORALABRLD2012-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021356-004VIREAD250MGTABLET / ORALABRLD2012-01-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021356-001VIREAD300MGTABLET / ORALABRLD, RS2001-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021356-002VIREAD150MGTABLET / ORALABRLD2012-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021356-003VIREAD200MGTABLET / ORALABRLD2012-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021356-004VIREAD250MGTABLET / ORALABRLD2012-01-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021356-001VIREAD300MGTABLET / ORALABRLD, RS2001-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021356-002VIREAD150MGTABLET / ORALABRLD2012-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021356-003VIREAD200MGTABLET / ORALABRLD2012-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021356-004VIREAD250MGTABLET / ORALABRLD2012-01-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021356-001VIREAD300MGTABLET / ORALABRLD, RS2001-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021356-002VIREAD150MGTABLET / ORALABRLD2012-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021356-003VIREAD200MGTABLET / ORALABRLD2012-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021356-004VIREAD250MGTABLET / ORALABRLD2012-01-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021356-001VIREAD300MGTABLET / ORALABRLD, RS2001-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021356-002VIREAD150MGTABLET / ORALABRLD2012-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021356-003VIREAD200MGTABLET / ORALABRLD2012-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021356-004VIREAD250MGTABLET / ORALABRLD2012-01-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021356-001VIREAD300MGTABLET / ORALABRLD, RS2001-10-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021356-002VIREAD150MGTABLET / ORALABRLD2012-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021356-003VIREAD200MGTABLET / ORALABRLD2012-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021356-004VIREAD250MGTABLET / ORALABRLD2012-01-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021356-001VIREAD300MGTABLET / ORALABRLD, RS2001-10-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021356-002VIREAD150MGTABLET / ORALABRLD2012-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021356-003VIREAD200MGTABLET / ORALABRLD2012-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021356-004VIREAD250MGTABLET / ORALABRLD2012-01-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021356-001VIREAD300MGTABLET / ORALABRLD, RS2001-10-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N021356-002VIREAD150MGTABLET / ORALABRLD2012-01-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N021356-003VIREAD200MGTABLET / ORALABRLD2012-01-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N021356-004VIREAD250MGTABLET / ORALABRLD2012-01-18d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021356-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021356-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021356-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021356-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021356-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021356-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021356-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021356-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021356-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021356-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021356-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021356-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021356-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021356-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021356-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021356-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021356-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021356-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021356-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021356-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021356-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021356-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021356-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021356-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021356-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021356-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021356-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021356-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021356-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021356-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021356-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021356-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021356-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021356-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021356-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021356-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021356-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021356-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021356-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021356-004AB1d06236e962d9…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021356-001PED2022-06-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021356-002PED2022-06-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021356-003PED2022-06-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021356-004PED2022-06-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021356-001PED2022-06-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021356-002PED2022-06-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021356-003PED2022-06-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021356-004PED2022-06-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021356-001PED2022-06-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021356-002PED2022-06-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021356-003PED2022-06-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021356-004PED2022-06-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021356-001NPP2021-12-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021356-001PED2022-06-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021356-002NPP2021-12-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021356-002PED2022-06-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021356-003NPP2021-12-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021356-003PED2022-06-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021356-004NPP2021-12-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021356-004PED2022-06-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021356-001PED2022-06-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021356-002PED2022-06-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021356-003PED2022-06-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021356-004PED2022-06-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021356-001NPP2021-12-11782e0a99824c…
2021-12-28 21:50 UTC2021-12N021356-001PED2022-06-11782e0a99824c…
2021-12-28 21:50 UTC2021-12N021356-002NPP2021-12-11782e0a99824c…
2021-12-28 21:50 UTC2021-12N021356-002PED2022-06-11782e0a99824c…
2021-12-28 21:50 UTC2021-12N021356-003NPP2021-12-11782e0a99824c…
2021-12-28 21:50 UTC2021-12N021356-003PED2022-06-11782e0a99824c…
2021-12-28 21:50 UTC2021-12N021356-004NPP2021-12-11782e0a99824c…
2021-12-28 21:50 UTC2021-12N021356-004PED2022-06-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021356-001NPP2021-12-1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021356-001PED2022-06-1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021356-002NPP2021-12-1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021356-002PED2022-06-1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021356-003NPP2021-12-1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021356-003PED2022-06-1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021356-004NPP2021-12-1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021356-004PED2022-06-1187673890dc5c…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.33fd6418-fbdc-42ca-a50d-ce2a476a54182025-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021356
application number: NDA021356
ndc (product): 61958-0405
ndc (product): 61958-0401
ndc (product): 61958-0406
ndc (product): 61958-0404

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-0754VireadTENOFOVIR DISOPROXIL FUMARATEA-S Medication SolutionsNDACurrent
50090-0754VireadTENOFOVIR DISOPROXIL FUMARATEA-S Medication SolutionsNDACurrent
53808-0810Vireadtenofovir disoproxil fumarateState of Florida DOH Central PharmacyNDACurrent
61958-0401VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0401VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0401VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0401VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0404VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0404VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0404VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0404VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0405VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0405VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0405VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0405VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0406VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0406VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0406VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0406VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
69189-0401VireadTENOFOVIR DISOPROXIL FUMARATEAvera McKennan HospitalNDACurrent
70518-0546VireadTENOFOVIR DISOPROXIL FUMARATEREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58410SUPPL2019-04-25
58393SUPPL2019-04-24
56862SUPPL2018-12-20
56706SUPPL2018-12-12
55069SUPPL2018-07-31
55059SUPPL2018-07-30
47982SUPPL2017-04-12
47913SUPPL2017-04-10
27578SUPPL2016-02-18
15279SUPPL2016-02-18
36744SUPPL2015-06-04
27577SUPPL2015-06-02
36743SUPPL2013-10-25
27576SUPPL2013-10-25
15278SUPPL2013-07-30
5151SUPPL2013-07-26
36742SUPPL2013-04-09
27575SUPPL2013-04-03
5150SUPPL2012-08-20
15277SUPPL2012-08-17
5149SUPPL2012-08-09
36741SUPPL2012-08-08
15275SUPPL2012-02-01
27573SUPPL2012-01-20
27574SUPPL2011-11-22
15276SUPPL2011-11-22
5148SUPPL2011-09-21
36740SUPPL2011-09-20
52368SUPPL2011-09-06
52367SUPPL2011-09-06
52366SUPPL2011-09-06
52365SUPPL2011-09-06
52364SUPPL2011-09-06
52363SUPPL2011-09-06
27572SUPPL2010-10-19
15274SUPPL2010-10-19
5147SUPPL2010-10-13
15273SUPPL2010-10-12
27571SUPPL2010-03-29
36739SUPPL2010-03-26
5146SUPPL2010-01-25
15272SUPPL2009-11-13
5145SUPPL2009-11-10
15271SUPPL2009-10-14
36738SUPPL2008-11-07
5144SUPPL2008-11-06
15270SUPPL2008-08-29
5143SUPPL2008-08-13
27570SUPPL2008-05-21
15269SUPPL2007-05-29
5142SUPPL2007-05-29
5140SUPPL2006-03-23
36736SUPPL2006-03-10
36737SUPPL2005-12-05
5141SUPPL2005-12-05
15268SUPPL2005-05-17
5139SUPPL2005-05-17
15267SUPPL2004-07-07
5138SUPPL2004-07-06
15266SUPPL2003-12-01
5137SUPPL2003-11-25
27569SUPPL2003-10-16
15265SUPPL2003-10-16
27568SUPPL2003-08-28
15264SUPPL2003-08-28
15263SUPPL2002-12-02
5136SUPPL2002-12-02
36735ORIG2001-10-26
21613ORIG2001-10-26
5135ORIG2001-10-26
63282SUPPL1900-01-01
63281SUPPL1900-01-01
63280SUPPL1900-01-01
52374ORIG1900-01-01
52373ORIG1900-01-01
52372ORIG1900-01-01
52371ORIG1900-01-01
52370ORIG1900-01-01
52369ORIG1900-01-01
51678ORIG1900-01-01
51677ORIG1900-01-01
51676ORIG1900-01-01