Home Applications 216332 Application 216332
Type ANDA
Sponsor LAURUS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE TABLET;ORAL EQ 600MG BASE;300MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR SULFATE; LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216332-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216332-001 ABACAVIR SULFATE AND LAMIVUDINE EQ 600MG BASE;300MG TABLET / ORAL AB 2022-07-25 a50c72e98297…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42385-962 Abacavir and Lamivudine Abacavir and Lamivudine Laurus Labs Limited ANDA Current