FDA.reportPublic FDA data

Application 021976

Type
NDA
Sponsor
JANSSEN PRODS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREZISTADARUNAVIRTABLET;ORAL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002PREZISTADARUNAVIRTABLET;ORAL600MGYesNo
003PREZISTADARUNAVIRTABLET;ORAL400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004PREZISTADARUNAVIRTABLET;ORAL75MGYesNo
005PREZISTADARUNAVIRTABLET;ORAL150MGYesNo
006PREZISTADARUNAVIRTABLET;ORAL800MGYesYes

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021976-001PREZISTADARUNAVIR300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-06-23
N021976-002PREZISTADARUNAVIR600MGTABLET / ORALABRLD2008-02-25
N021976-003PREZISTADARUNAVIR400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-10-21
N021976-004PREZISTADARUNAVIR75MGTABLET / ORALABRLD2008-12-18
N021976-005PREZISTADARUNAVIR150MGTABLET / ORALABRLD2008-12-18
N021976-006PREZISTADARUNAVIR800MGTABLET / ORALABRLD, RS2012-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021976-002AB
N021976-004AB
N021976-005AB
N021976-006AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021976-00177006452026-12-26Drug substance, Drug product
N021976-0017700645*PED2027-06-26Pediatric extension
N021976-00277006452026-12-26Drug substance, Drug product
N021976-0027700645*PED2027-06-26Pediatric extension
N021976-00377006452026-12-26Drug substance, Drug product
N021976-0037700645*PED2027-06-26Pediatric extension
N021976-00477006452026-12-26Drug substance, Drug product
N021976-0047700645*PED2027-06-26Pediatric extension
N021976-00577006452026-12-26Drug substance, Drug product
N021976-0057700645*PED2027-06-26Pediatric extension
N021976-00677006452026-12-26Drug substance, Drug product
N021976-0067700645*PED2027-06-26Pediatric extension

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021976-001PREZISTA300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-002PREZISTA600MGTABLET / ORALABRLD2008-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-003PREZISTA400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-004PREZISTA75MGTABLET / ORALABRLD2008-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-005PREZISTA150MGTABLET / ORALABRLD2008-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-006PREZISTA800MGTABLET / ORALABRLD, RS2012-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-001PREZISTA300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-002PREZISTA600MGTABLET / ORALABRLD2008-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-003PREZISTA400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-10-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-004PREZISTA75MGTABLET / ORALABRLD2008-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-005PREZISTA150MGTABLET / ORALABRLD2008-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-006PREZISTA800MGTABLET / ORALABRLD, RS2012-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021976-001PREZISTA300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-002PREZISTA600MGTABLET / ORALABRLD2008-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-003PREZISTA400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-10-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-004PREZISTA75MGTABLET / ORALABRLD2008-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-005PREZISTA150MGTABLET / ORALABRLD2008-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-006PREZISTA800MGTABLET / ORALABRLD, RS2012-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021976-001PREZISTA300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021976-002PREZISTA600MGTABLET / ORALABRLD2008-02-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021976-003PREZISTA400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-10-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021976-004PREZISTA75MGTABLET / ORALRLD2008-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021976-005PREZISTA150MGTABLET / ORALRLD2008-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021976-006PREZISTA800MGTABLET / ORALABRLD, RS2012-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021976-001PREZISTA300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021976-002PREZISTA600MGTABLET / ORALABRLD2008-02-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021976-003PREZISTA400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-10-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021976-004PREZISTA75MGTABLET / ORALRLD2008-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021976-005PREZISTA150MGTABLET / ORALRLD2008-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021976-006PREZISTA800MGTABLET / ORALABRLD, RS2012-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021976-001PREZISTA300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-06-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021976-002PREZISTA600MGTABLET / ORALABRLD2008-02-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021976-003PREZISTA400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-10-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021976-004PREZISTA75MGTABLET / ORALRLD2008-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021976-005PREZISTA150MGTABLET / ORALRLD2008-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021976-006PREZISTA800MGTABLET / ORALABRLD, RS2012-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021976-001PREZISTA300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-06-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021976-002PREZISTA600MGTABLET / ORALABRLD2008-02-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021976-003PREZISTA400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-10-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021976-004PREZISTA75MGTABLET / ORALRLD2008-12-182680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021976-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021976-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021976-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021976-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021976-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021976-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021976-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021976-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021976-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021976-006AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021976-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021976-006AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021976-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021976-006AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021976-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021976-006AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021976-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021976-006AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021976-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021976-006AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021976-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021976-006AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021976-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021976-006AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021976-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021976-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021976-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021976-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021976-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021976-002AB1782e0a99824c…

Observed Orange Book patent history#

Patent history page 1 of 28 · 1,088 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021976-00177006452026-12-26Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-0017700645*PED2027-06-26Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-00277006452026-12-26Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-0027700645*PED2027-06-26Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-00377006452026-12-26Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-0037700645*PED2027-06-26Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-00477006452026-12-26Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-0047700645*PED2027-06-26Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-00577006452026-12-26Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-0057700645*PED2027-06-26Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-00677006452026-12-26Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021976-0067700645*PED2027-06-26Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-00177006452026-12-26Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-0017700645*PED2027-06-26Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-00277006452026-12-26Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-0027700645*PED2027-06-26Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-00377006452026-12-26Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-0037700645*PED2027-06-26Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-00477006452026-12-26Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-0047700645*PED2027-06-26Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-00577006452026-12-26Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-0057700645*PED2027-06-26Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-00677006452026-12-26Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021976-0067700645*PED2027-06-26Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N021976-00177006452026-12-26Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-0017700645*PED2027-06-26Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-00277006452026-12-26Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-0027700645*PED2027-06-26Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-00377006452026-12-26Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-0037700645*PED2027-06-26Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-00477006452026-12-26Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-0047700645*PED2027-06-26Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-00577006452026-12-26Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-0057700645*PED2027-06-26Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-00677006452026-12-26Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021976-0067700645*PED2027-06-26Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021976-00177006452026-12-26Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021976-0017700645*PED2027-06-26Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021976-00277006452026-12-26Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021976-0027700645*PED2027-06-26Pediatric extensionfd3edfee7708…

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
PREZISTADARUNAVIRJanssen Products LP814301f9-c990-46a5-b481-2879a521a16f2025-08-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 021976
application number: NDA021976
ndc (product): 59676-566
ndc (product): 59676-562
ndc (product): 59676-563
ndc (product): 59676-564

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 64 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1327PREZISTAdarunavirA-S Medication SolutionsNDACurrent
50090-1491PREZISTAdarunavirA-S Medication SolutionsNDACurrent
50090-1491PREZISTAdarunavirA-S Medication SolutionsNDACurrent
53808-0672PREZISTAdarunavir ethanolateState of Florida DOH Central PharmacyNDACurrent
53808-0773PREZISTAdarunavir ethanolateState of Florida DOH Central PharmacyNDACurrent
59676-562PREZISTAdarunavirJanssen Products LPNDACurrent
59676-562PREZISTAdarunavirJanssen Products LPNDACurrent
59676-562PREZISTAdarunavirJanssen Products LPNDACurrent
59676-562PREZISTAdarunavirJanssen Products LPNDACurrent
59676-562PREZISTAdarunavirJanssen Products LPNDACurrent
59676-562PREZISTAdarunavirJanssen Products LPNDACurrent
59676-562PREZISTAdarunavirJanssen Products LPNDACurrent
59676-562PREZISTAdarunavirJanssen Products LPNDACurrent
59676-562PREZISTAdarunavirJanssen Products LPNDACurrent
59676-562PREZISTAdarunavirJanssen Products LPNDACurrent
59676-562PREZISTAdarunavirJanssen Products LPNDACurrent
59676-562PREZISTAdarunavirJanssen Products LPNDACurrent
59676-562PREZISTAdarunavirJanssen Products LPNDACurrent
59676-563PREZISTAdarunavirJanssen Products LPNDACurrent
59676-563PREZISTAdarunavirJanssen Products LPNDACurrent
59676-563PREZISTAdarunavirJanssen Products LPNDACurrent
59676-563PREZISTAdarunavirJanssen Products LPNDACurrent
59676-563PREZISTAdarunavirJanssen Products LPNDACurrent
59676-563PREZISTAdarunavirJanssen Products LPNDACurrent
59676-563PREZISTAdarunavirJanssen Products LPNDACurrent
59676-563PREZISTAdarunavirJanssen Products LPNDACurrent
59676-563PREZISTAdarunavirJanssen Products LPNDACurrent
59676-563PREZISTAdarunavirJanssen Products LPNDACurrent
59676-563PREZISTAdarunavirJanssen Products LPNDACurrent
59676-563PREZISTAdarunavirJanssen Products LPNDACurrent
59676-563PREZISTAdarunavirJanssen Products LPNDACurrent
59676-564PREZISTAdarunavirJanssen Products LPNDACurrent
59676-564PREZISTAdarunavirJanssen Products LPNDACurrent
59676-564PREZISTAdarunavirJanssen Products LPNDACurrent
59676-564PREZISTAdarunavirJanssen Products LPNDACurrent
59676-564PREZISTAdarunavirJanssen Products LPNDACurrent
59676-564PREZISTAdarunavirJanssen Products LPNDACurrent
59676-564PREZISTAdarunavirJanssen Products LPNDACurrent
59676-564PREZISTAdarunavirJanssen Products LPNDACurrent
59676-564PREZISTAdarunavirJanssen Products LPNDACurrent
59676-564PREZISTAdarunavirJanssen Products LPNDACurrent
59676-564PREZISTAdarunavirJanssen Products LPNDACurrent
59676-564PREZISTAdarunavirJanssen Products LPNDACurrent
59676-564PREZISTAdarunavirJanssen Products LPNDACurrent
59676-566PREZISTAdarunavirJanssen Products LPNDACurrent
59676-566PREZISTAdarunavirJanssen Products LPNDACurrent
59676-566PREZISTAdarunavirJanssen Products LPNDACurrent
59676-566PREZISTAdarunavirJanssen Products LPNDACurrent
59676-566PREZISTAdarunavirJanssen Products LPNDACurrent
59676-566PREZISTAdarunavirJanssen Products LPNDACurrent
59676-566PREZISTAdarunavirJanssen Products LPNDACurrent
59676-566PREZISTAdarunavirJanssen Products LPNDACurrent
59676-566PREZISTAdarunavirJanssen Products LPNDACurrent
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Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73925SUPPL 2023-04-03
72458SUPPL2022-10-24
72441SUPPL2022-10-21
70775SUPPL2022-04-15
70772SUPPL2022-04-15
68739SUPPL2021-09-23
68399SUPPL2021-08-18
68205SUPPL2021-07-27
68188SUPPL2021-07-26
65757SUPPL2020-12-28
65719SUPPL2020-12-23
58959SUPPL2019-06-04
58881SUPPL2019-05-30
58068SUPPL2019-03-25
58062SUPPL2019-03-22
57560SUPPL2019-02-13
57406SUPPL2019-02-01
55441SUPPL2018-09-12
55420SUPPL2018-09-10
52423SUPPL2018-02-06
52100SUPPL2018-01-30
48895SUPPL2017-07-05
48793SUPPL2017-06-22
45335SUPPL2016-09-20
45309SUPPL2016-09-15
37974SUPPL2016-06-21
28953SUPPL2016-06-21
37973SUPPL2015-05-29
6566SUPPL2015-05-28
16669SUPPL2015-04-02
28952SUPPL2015-04-01
28951SUPPL2014-04-08
16668SUPPL2014-04-08
16667SUPPL2013-11-08
6565SUPPL2013-11-08
16664SUPPL2013-04-29
6563SUPPL2013-04-25
28950SUPPL2013-02-26
16666SUPPL2013-02-26
37972SUPPL2013-02-06
16665SUPPL2013-02-06
28949SUPPL2013-02-04
6564SUPPL2013-02-04
37971SUPPL2012-11-15
28948SUPPL2012-06-07
16663SUPPL2012-06-06
16662SUPPL2012-02-24
6562SUPPL2012-02-23
6561SUPPL2012-02-15
37970SUPPL2012-02-14
28947SUPPL2011-12-27
16661SUPPL2011-12-23
37969SUPPL2011-10-25
6560SUPPL2011-10-24
6559SUPPL2010-12-15
16660SUPPL2010-12-13
16659SUPPL2010-05-03
28946SUPPL2010-04-29
28945SUPPL2010-02-05
6558SUPPL2010-02-05
37968SUPPL2010-02-04
16658SUPPL2010-02-04
37967SUPPL2009-06-22
16657SUPPL2009-06-22
6557SUPPL2009-06-17
6556SUPPL2009-06-17
16656SUPPL2009-01-02
28944SUPPL2008-12-29
16655SUPPL2008-11-07
6555SUPPL2008-10-23
6554SUPPL2008-10-23
37965SUPPL2008-03-12
37964SUPPL2008-03-12
28942SUPPL2008-03-11
6553SUPPL2008-03-11
28943SUPPL2008-02-27
37966SUPPL2008-02-26
51506SUPPL2007-08-16
44163ORIG2006-12-08
28941SUPPL2006-12-04
16654SUPPL2006-11-22
51504SUPPL2006-11-17
21890ORIG2006-09-06
16653ORIG2006-06-28
28940ORIG2006-06-27
52599ORIG1900-01-01
52598ORIG1900-01-01