Home Applications 202073 Application 202073
Type ANDA
Sponsor LUPIN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DARUNAVIR DARUNAVIR TABLET;ORAL 75MG No No 002 DARUNAVIR DARUNAVIR TABLET;ORAL 150MG No No 003 DARUNAVIR DARUNAVIR TABLET;ORAL 300MG No No 004 DARUNAVIR DARUNAVIR TABLET;ORAL 400MG No No 005 DARUNAVIR DARUNAVIR TABLET;ORAL 600MG No No 006 DARUNAVIR DARUNAVIR TABLET;ORAL 800MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A202073-001 DARUNAVIR DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 A202073-002 DARUNAVIR DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29
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 · 52 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 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202073-001 DARUNAVIR 600MG TABLET / ORAL AB 2022-09-29 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202073-002 DARUNAVIR 800MG TABLET / ORAL AB 2022-09-29 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A202073-002 PC 2023-11-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202073-002 PC 2023-11-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202073-002 PC 2023-11-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202073-002 PC 2023-11-28 a67488948f0b…
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 Lupin Pharmaceuticals, Inc. 56daf67e-7501-4cd5-be22-566d7997d42e 2025-10-23 Warnings, Adverse reactions Exact identifier application applno (ANDA): 202073 application number: ANDA202073
Documents# Document, Submission type, Date table Document Submission type Date 72731 ORIG 2022-11-28