FDA.reportPublic FDA data

Application 201152

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIRAMUNE XRNEVIRAPINETABLET, EXTENDED RELEASE;ORAL400MGYesYes
002VIRAMUNE XRNEVIRAPINETABLET, EXTENDED RELEASE;ORAL100MGYesNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N201152-001VIRAMUNE XRNEVIRAPINE400MGTABLET, EXTENDED RELEASE / ORALRLD2011-03-25
N201152-002VIRAMUNE XRNEVIRAPINE100MGTABLET, EXTENDED RELEASE / ORALRLD2012-11-08

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N201152-00184607042029-03-12U-14092013-06-21

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 22:54:322026-06N201152-001VIRAMUNE XR400MGTABLET, EXTENDED RELEASE / ORALRLD2011-03-25a50c72e98297…
2026-08-01 22:54:322026-06N201152-002VIRAMUNE XR100MGTABLET, EXTENDED RELEASE / ORALRLD2012-11-08a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N201152-00184607042029-03-12U-14092013-06-21a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NEVIRAPINENEVIRAPINEMicro Labs Limitedfbd628db-4076-4fe0-8323-9cc33ae92e422025-10-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE
NevirapineNEVIRAPINEMylan Pharmaceuticals Inc.690da74b-2481-47fc-93ae-8340e0caf0a42024-10-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE
NevirapineNEVIRAPINEAurobindo Pharma Limited8dfe86aa-ea5d-48d2-94a8-1a5506055d702024-09-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE
NEVIRAPINENEVIRAPINEMacleods Pharmaceuticals Limited2620b114-f53f-44f1-8708-697e863430902024-08-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE
NevirapineNEVIRAPINEAurobindo Pharma Limited5f6c3eed-2a5d-46ed-9a7c-59715f338a152024-05-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE
NevirapineNEVIRAPINEMylan Pharmaceuticals Inc.c6e93829-7024-48f6-8023-da6ff27dfc0a2024-01-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE
NevirapineNEVIRAPINEMacleods Pharmaceuticals Limitedeffb86cc-4b80-4fac-aaa3-9f373b3d0f7d2023-08-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE
NevirapineNEVIRAPINECamber Pharmaceuticals, Inc.61409678-d2f6-42cd-b03d-b26b11b396412022-08-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE
NevirapineNEVIRAPINEAmneal Pharmaceuticals LLC4f065674-4719-4c79-ba0d-549040d77f172012-08-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0123ViramunenevirapineBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0123ViramunenevirapineBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0123ViramunenevirapineBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0123ViramunenevirapineBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0123ViramunenevirapineBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79164SUPPL 2024-07-24
79163SUPPL 2024-07-24
79150SUPPL 2024-07-23
71319SUPPL2022-06-15
71318SUPPL2022-06-15
71276SUPPL2022-06-13
55744SUPPL2018-10-01
55611SUPPL2018-09-25
55610SUPPL2018-09-25
47764SUPPL2017-03-29
47739SUPPL2017-03-28
18993SUPPL2014-01-28
9863SUPPL2014-01-28
9861SUPPL2012-11-13
18991SUPPL2012-11-08
18992SUPPL2012-10-04
9862SUPPL2012-10-03
44830ORIG2012-06-29
22844ORIG2012-06-29
24098ORIG2011-11-17
32084SUPPL2011-11-14
40050SUPPL2011-11-10
9860SUPPL2011-05-10
18990ORIG2011-03-29
9859ORIG2011-03-29
63228ORIG1900-01-01
54064ORIG1900-01-01
51403ORIG1900-01-01
51402ORIG1900-01-01