Home Applications 020857 Application 020857
Type NDA
Sponsor VIIV HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 COMBIVIR LAMIVUDINE; ZIDOVUDINE TABLET;ORAL 150MG;300MG Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020857-001 COMBIVIR LAMIVUDINE; ZIDOVUDINE 150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-26
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 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020857-001 COMBIVIR 150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020857-001 COMBIVIR 150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020857-001 COMBIVIR 150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020857-001 COMBIVIR 150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020857-001 COMBIVIR 150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020857-001 COMBIVIR 150MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL RLD 1997-09-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020857-001 COMBIVIR 150MG;300MG TABLET / ORAL AB RLD, RS 1997-09-26 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join COMBIVIR LAMIVUDINE AND ZIDOVUDINE ViiV Healthcare Company 16da660b-9981-4d24-a14a-94c7744fce4f 2023-08-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020857 application number: NDA020857 ndc (product): 49702-202
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 21695-846 COMBIVIR lamivudine and zidovudine Rebel Distributors Corp NDA Current 49702-202 COMBIVIR lamivudine and zidovudine ViiV Healthcare Company NDA Current 49702-202 COMBIVIR lamivudine and zidovudine ViiV Healthcare Company NDA Current 49702-202 COMBIVIR lamivudine and zidovudine ViiV Healthcare Company NDA Current 49702-202 COMBIVIR lamivudine and zidovudine ViiV Healthcare Company NDA Current 49702-202 COMBIVIR lamivudine and zidovudine ViiV Healthcare Company NDA Current 50090-0610 COMBIVIR lamivudine and zidovudine A-S Medication Solutions NDA Current 52959-546 COMBIVIR lamivudine and zidovudine H.J. Harkins Company, Inc. NDA Current 53808-0895 COMBIVIR lamivudine and zidovudine State of Florida DOH Central Pharmacy NDA Current