Home Applications 202083 Application 202083
Type ANDA
Sponsor HETERO LABS UNIT III Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DARUNAVIR DARUNAVIR TABLET;ORAL 400MG No No 002 DARUNAVIR DARUNAVIR TABLET;ORAL 600MG No No 003 DARUNAVIR DARUNAVIR TABLET;ORAL 150MG No No 004 DARUNAVIR DARUNAVIR TABLET;ORAL 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202083-001 DARUNAVIR DARUNAVIR 400MG TABLET / ORAL AB 2023-09-14 A202083-002 DARUNAVIR DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 42 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 2026-08-18 06:07:40 2026-07 A202083-001 DARUNAVIR 400MG TABLET / ORAL AB 2023-09-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202083-001 DARUNAVIR 400MG TABLET / ORAL AB 2023-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202083-001 DARUNAVIR 400MG TABLET / ORAL AB 2023-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202083-001 DARUNAVIR 400MG TABLET / ORAL AB 2023-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202083-001 DARUNAVIR 400MG TABLET / ORAL 2023-09-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202083-001 DARUNAVIR 400MG TABLET / ORAL 2023-09-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202083-001 DARUNAVIR 400MG TABLET / ORAL 2023-09-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202083-001 DARUNAVIR 400MG TABLET / ORAL 2023-09-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202083-001 DARUNAVIR 400MG TABLET / ORAL 2023-09-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202083-001 DARUNAVIR 400MG TABLET / ORAL 2023-09-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202083-001 DARUNAVIR 400MG TABLET / ORAL 2023-09-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202083-001 DARUNAVIR 400MG TABLET / ORAL 2023-09-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202083-001 DARUNAVIR 400MG TABLET / ORAL 2023-09-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202083-001 DARUNAVIR 400MG TABLET / ORAL 2023-09-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202083-001 DARUNAVIR 400MG TABLET / ORAL 2023-09-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202083-001 DARUNAVIR 400MG TABLET / ORAL 2023-09-14 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202083-001 DARUNAVIR 400MG TABLET / ORAL 2023-09-14 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202083-001 DARUNAVIR 400MG TABLET / ORAL 2023-09-14 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202083-001 DARUNAVIR 400MG TABLET / ORAL 2023-09-14 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202083-001 DARUNAVIR 400MG TABLET / ORAL 2023-09-14 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202083-002 DARUNAVIR 600MG TABLET / ORAL AB 2023-09-14 9b2671bbb829…
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 Darunavir DARUNAVIR Camber Pharmaceuticals, Inc. 64160982-e682-4e8d-8800-a89321112211 2023-10-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 202083 application number: ANDA202083