Application 209512

Type
NDA
Sponsor
ABBVIE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORVIRRITONAVIRPOWDER;ORAL100MG/PACKETYesYes

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

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
N209512-001NORVIRRITONAVIR100MG/PACKETPOWDER / ORALRLD, RS2017-06-07

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N209512-001NORVIR100MG/PACKETPOWDER / ORALRLD, RS2017-06-07a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NorvirRITONAVIRAbbVie Inc.2849298e-de6e-47bb-8194-56e075b33fc32024-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 209512
application number: NDA209512
ndc (product): 0074-3399

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-3399NorvirRitonavirAbbVie Inc.NDACurrent
0074-3399NorvirRitonavirAbbVie Inc.NDACurrent
0074-3399NorvirRitonavirAbbVie Inc.NDACurrent
0074-3399NorvirRitonavirAbbVie Inc.NDACurrent
0074-3399NorvirRitonavirAbbVie Inc.NDACurrent
0074-3399NorvirRitonavirAbbVie Inc.NDACurrent
0074-3399NorvirRitonavirAbbVie Inc.NDACurrent
0074-3399NorvirRitonavirAbbVie Inc.NDACurrent
0074-3399NorvirRitonavirAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72960SUPPL2022-12-20
72918SUPPL2022-12-16
65024SUPPL2020-10-23
64975SUPPL2020-10-22
61484SUPPL2019-12-31
61379SUPPL2019-12-23
59816SUPPL2019-08-22
59805SUPPL2019-08-22
56683SUPPL2018-12-07
56542SUPPL2018-11-23
52958ORIG2018-03-14
52853ORIG2018-03-08
49926SUPPL2017-10-03
49919SUPPL2017-10-03
48886SUPPL2017-06-30
48878SUPPL2017-06-30
48671ORIG2017-06-08