FDA.reportPublic FDA data

Application 079081

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMIVUDINE AND ZIDOVUDINELAMIVUDINE; ZIDOVUDINETABLET;ORAL150MG;300MGNoNo

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
A079081-001LAMIVUDINE AND ZIDOVUDINELAMIVUDINE; ZIDOVUDINE150MG;300MGTABLET / ORAL2011-05-25

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 UTC2022-10A079081-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORAL2011-05-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079081-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORAL2011-05-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079081-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORAL2011-05-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A079081-001LAMIVUDINE AND ZIDOVUDINE150MG;300MGTABLET / ORAL2011-05-25a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lamivudine and ZidovudineLAMIVUDINE AND ZIDOVUDINECamber Pharmaceuticals, Inc.e816e8f5-1e50-4f49-8bea-92da0121d26e2026-03-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamivudine and Zidovudine
LAMIVUDINE and ZIDOVUDINELAMIVUDINE AND ZIDOVUDINEPD-Rx Pharmaceuticals, Inc.ff62c5fc-965d-4534-a571-a4f290cb9d832025-10-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LAMIVUDINE and ZIDOVUDINE
Lamivudine and ZidovudineLAMIVUDINE AND ZIDOVUDINEAurobindo Pharma Limitedd40292ff-046c-4a04-b801-10768667951a2024-05-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamivudine and Zidovudine
Lamivudine and ZidovudineLAMIVUDINE AND ZIDOVUDINEBryant Ranch Prepack61d14a88-9fdf-4373-8360-44ec9e1cd3502024-04-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamivudine and Zidovudine
Lamivudine and ZidovudineLAMIVUDINE AND ZIDOVUDINEMacleods Pharmaceuticals Limited63667952-be01-483e-9887-1d5417e7ec162023-07-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamivudine and Zidovudine
LAMIVUDINE and ZIDOVUDINELAMIVUDINE AND ZIDOVUDINEBryant Ranch Prepack005f1b9d-1950-4ef3-a9d6-c428a40a36302023-03-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LAMIVUDINE and ZIDOVUDINE
LAMIVUDINE AND ZIDOVUDINELAMIVUDINE AND ZIDOVUDINEXLCare Pharmaceuticals, Inc55520835-0f24-4e52-af8c-d65841ccaba72023-01-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LAMIVUDINE AND ZIDOVUDINE
LAMIVUDINE and ZIDOVUDINELAMIVUDINE AND ZIDOVUDINECamber Pharmaceuticals, Inc.f80bd0f3-47eb-4b82-a633-4536cf376cf62022-09-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LAMIVUDINE and ZIDOVUDINE
Lamivudine and ZidovudineLAMIVUDINE AND ZIDOVUDINEExelan Pharmaceuticals Inc.4cf565c3-bdec-4c18-93c1-cc7fa8331c902019-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lamivudine and Zidovudine

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-996Lamivudine and ZidovudineLamivudine and ZidovudineRebel Distributors CorpANDACurrent
42291-363Lamivudine and ZidovudineLamivudine and ZidovudineAvKARE, Inc.ANDACurrent
43063-346Lamivudine and ZidovudineLamivudine and ZidovudinePD-Rx Pharmaceuticals, Inc.ANDACurrent
70518-0697Lamivudine and ZidovudineLamivudine and ZidovudineREMEDYREPACK INC.ANDACurrent
76519-1005Lamivudine and ZidovudineLamivudine and ZidovudineH.J. Harkins Company, Inc.ANDACurrent