Home Applications 207407 Application 207407
Type ANDA
Sponsor LANNETT CO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LOPINAVIR AND RITONAVIR LOPINAVIR; RITONAVIR SOLUTION;ORAL 80MG/ML;20MG/ML 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 A207407-001 LOPINAVIR AND RITONAVIR LOPINAVIR; RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL 2016-12-27
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 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL 2016-12-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL 2016-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207407-001 LOPINAVIR AND RITONAVIR 80MG/ML;20MG/ML SOLUTION / ORAL AA 2016-12-27 e64feba35796…
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 · 3 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0527-1947 Lopinavir-Ritonavir Lopinavir-Ritonavir Lannett Company, Inc. ANDA Current 0527-1947 Lopinavir-Ritonavir Lopinavir-Ritonavir Lannett Company, Inc. ANDA Current 0527-1947 Lopinavir-Ritonavir Lopinavir-Ritonavir Lannett Company, Inc. ANDA Current 0527-1947 Lopinavir-Ritonavir Lopinavir-Ritonavir Lannett Company, Inc. ANDA Current 0527-1947 Lopinavir-Ritonavir Lopinavir-Ritonavir Lannett Company, Inc. ANDA Current 0527-1947 Lopinavir-Ritonavir Lopinavir-Ritonavir Lannett Company, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 47077 ORIG 2017-01-31 46585 ORIG 2016-12-29