FDA.reportPublic FDA data

Application 021004

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPIVIR-HBVLAMIVUDINESOLUTION;ORAL5MG/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021004-001EPIVIR-HBVLAMIVUDINE5MG/MLSOLUTION / ORALRLD1998-12-08

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N021004-001EPIVIR-HBV5MG/MLSOLUTION / ORALRLD, RS1998-12-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021004-001EPIVIR-HBV5MG/MLSOLUTION / ORALRLD, RS1998-12-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021004-001EPIVIR-HBV5MG/MLSOLUTION / ORALRLD1998-12-08a50c72e98297…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LamivudineLAMIVUDINECamber Pharmaceuticals, Inc.6bd6b9da-df69-46db-813e-4e7f3bdecf952026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMIVUDINE
LAMIVUDINELAMIVUDINEMajor Pharmaceuticals6fd4d6b9-65ea-4988-8d6f-dd220ec5052d2026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMIVUDINE
LamivudineLAMIVUDINEStrides Pharma Science Limitedac824c7e-9c9f-487b-ad2f-d50eaef5cbda2026-01-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMIVUDINE
LAMIVUDINELAMIVUDINEGolden State Medical Supply, Inc.f3637209-303e-4232-ae79-07315a9909732025-11-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMIVUDINE
LAMIVUDINELAMIVUDINEApotex Corp.34c02bcc-d6ff-99d4-8e6a-4a91908adca82025-09-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMIVUDINE
LamivudineLAMIVUDINEGolden State Medical Supply, Inc.3c30216d-f9f5-104b-e063-6294a90af8fd2025-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMIVUDINE
LamivudineLAMIVUDINEApotex Corp.87095352-c088-74b1-7be0-d3e293a906112025-06-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMIVUDINE
LamivudineLAMIVUDINECoupler LLC2d7db3b2-9b3c-3031-e063-6294a90a342c2025-02-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMIVUDINE
lamivudineLAMIVUDINECamber Pharmaceuticals, Inc.e90671c6-7fff-48f4-8898-29f02d049c8b2025-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMIVUDINE
LamivudineLAMIVUDINECamber Pharmaceuticals, Inc.49d53e74-3798-4463-b817-1c8beb7550342025-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMIVUDINE
LamivudineLAMIVUDINEAmerican Health Packaging7ad3a998-8e4d-43a0-8930-8f7a6ae539b42024-09-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMIVUDINE
LamivudineLAMIVUDINEAurobindo Pharma Limiteda8a492ab-396a-4b7c-99b3-bcb6d3386f712024-04-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMIVUDINE
LamivudineLAMIVUDINERising Pharma Holdings, Inc.bed2e227-8d36-40ea-bbbf-d8793bfda4252024-04-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMIVUDINE
LamivudineLAMIVUDINEAurobindo Pharma Limitedba7ee31e-e8d4-4e17-b27a-d2ce69e3bb002024-04-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMIVUDINE
LamivudineLAMIVUDINELupin Pharmaceuticals, Inc.ff3b5265-f533-4332-a861-d8c9c1664ffd2024-01-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMIVUDINE
LamivudineLAMIVUDINEMacleods Pharmaceuticals Limited1be30bcc-2d9f-4afc-8f09-adc840b3f2d92022-12-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMIVUDINE
LamivudineLAMIVUDINEIngenus Pharmaceuticals, LLC47f8be59-178c-4bad-96a4-a5c82784f3082018-12-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LAMIVUDINE

Reported adverse events (FAERS/openFDA)#

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

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
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69777SUPPL2021-12-27
69758SUPPL2021-12-27
56686SUPPL2018-12-07
56548SUPPL2018-11-23
49887SUPPL2017-09-29
49871SUPPL2017-09-28
48342SUPPL2017-05-10
48329SUPPL2017-05-09
26457SUPPL2013-12-24
35861SUPPL2013-12-23
26456SUPPL2011-01-27
14144SUPPL2011-01-24
35860SUPPL2007-10-04
4015SUPPL2007-10-04
14143SUPPL2004-12-03
4013SUPPL2004-12-02
35859SUPPL2004-09-29
4014SUPPL2004-09-29
35858SUPPL2003-12-01
26455SUPPL2003-11-25
35857SUPPL2001-08-16
21348SUPPL2001-08-16
4012SUPPL2001-08-16
41870ORIG1998-12-08
35856ORIG1998-12-08
4011ORIG1998-12-08