FDA.reportPublic FDA data

Application 020945

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORVIRRITONAVIRCAPSULE;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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
N020945-001NORVIRRITONAVIR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1999-06-29

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 UTC2022-10N020945-001NORVIR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1999-06-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020945-001NORVIR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1999-06-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020945-001NORVIR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1999-06-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020945-001NORVIR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1999-06-29a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020945-00171415932020-05-22Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020945-00174322942020-05-22Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020945-0017141593*PED2020-11-22Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020945-0017432294*PED2020-11-22Pediatric extension74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N020945-00171415932020-05-22Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N020945-00174322942020-05-22Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N020945-0017141593*PED2020-11-22Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020945-0017432294*PED2020-11-22Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N020945-00171415932020-05-22Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N020945-00174322942020-05-22Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N020945-0017141593*PED2020-11-22Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020945-0017432294*PED2020-11-22Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N020945-00171415932020-05-22Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N020945-00174322942020-05-22Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N020945-0017141593*PED2020-11-22Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020945-0017432294*PED2020-11-22Pediatric extensionea99ee380514…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RitonavirRITONAVIRAmneal Pharmaceuticals LLCa32cb2e3-d4e5-4bbf-9d88-20b2b249e7792026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RITONAVIR
NorvirRITONAVIRAbbVie Inc.2849298e-de6e-47bb-8194-56e075b33fc32026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Norvir
generic name: RITONAVIR
RitonavirRITONAVIRBryant Ranch Prepackd2f8c6ba-5e06-4b03-8ca5-b4fd7e5a89252026-03-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RITONAVIR
RitonavirRITONAVIRNuCare Pharmaceuticals, Inc.3f92f1e2-59f4-f6c4-e063-6294a90a487b2025-09-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RITONAVIR
RitonavirRITONAVIRBryant Ranch Prepack3c811e3e-f685-4af7-a4d1-037f2613ee682025-06-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RITONAVIR
RitonavirRITONAVIRAmerican Health Packaging19503bc4-3443-4ad4-aa27-437f4f3288b12024-04-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RITONAVIR
RitonavirRITONAVIRCamber Pharmaceuticals, Inc.db633374-6d8e-4622-9fe1-f9d68baa59bb2023-02-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RITONAVIR

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65013SUPPL2020-10-23
64976SUPPL2020-10-22
61480SUPPL2019-12-31
61381SUPPL2019-12-23
59819SUPPL2019-08-22
59807SUPPL2019-08-22
56684SUPPL2018-12-07
56546SUPPL2018-11-23
48883SUPPL2017-06-30
48879SUPPL2017-06-30
46851SUPPL2017-01-17
46513SUPPL2016-12-22
45999SUPPL2016-12-02
45947SUPPL2016-11-23
45330SUPPL2016-09-20
45319SUPPL2016-09-16
3832SUPPL2015-11-13
13803SUPPL2015-11-12
13802SUPPL2015-04-02
26277SUPPL2015-04-01
26276SUPPL2015-03-18
35701SUPPL2015-03-17
26275SUPPL2013-11-08
13801SUPPL2013-11-08
35700SUPPL2012-11-28
3831SUPPL2012-11-21
3829SUPPL2012-04-02
35699SUPPL2012-03-29
3830SUPPL2012-02-23
13800SUPPL2012-02-22
35698SUPPL2011-12-14
3828SUPPL2011-12-08
35697SUPPL2010-05-07
26274SUPPL2010-04-29
3827SUPPL2010-01-20
35696SUPPL2009-12-02
13799SUPPL2009-08-04
3826SUPPL2008-10-02
26273SUPPL2008-09-03
13798SUPPL2008-08-29
3825SUPPL2008-05-20
41830SUPPL2007-11-19
41829SUPPL2007-11-19
35695SUPPL2007-08-02
26272SUPPL2007-08-02
26271SUPPL2007-05-16
13797SUPPL2007-05-16
3824SUPPL2005-11-18
35693SUPPL2005-11-17
26270SUPPL2005-10-11
35694SUPPL2005-10-10
26269SUPPL2005-03-30
13796SUPPL2005-03-30
26267ORIG2004-06-10
13793ORIG2004-06-10
41828ORIG2004-03-28
13795SUPPL2003-09-25
3823SUPPL2003-09-25
13794SUPPL2003-04-25
35692SUPPL2002-03-14
3822SUPPL2002-03-14
26268SUPPL2001-03-06
63732ORIG1900-01-01
63731ORIG1900-01-01
63730ORIG1900-01-01
63729ORIG1900-01-01