Home Applications 021906 Application 021906
Type NDA
Sponsor ABBVIE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KALETRA LOPINAVIR; RITONAVIR TABLET;ORAL 200MG;50MG Yes Yes 002 KALETRA LOPINAVIR; RITONAVIR TABLET;ORAL 100MG;25MG Yes 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 N021906-001 KALETRA LOPINAVIR; RITONAVIR 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 N021906-002 KALETRA LOPINAVIR; RITONAVIR 100MG;25MG TABLET / ORAL AB RLD 2007-11-09
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 3 · 82 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 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021906-001 KALETRA 200MG;50MG TABLET / ORAL RLD, RS 2005-10-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 KALETRA 100MG;25MG TABLET / ORAL RLD 2007-11-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021906-001 KALETRA 200MG;50MG TABLET / ORAL AB RLD, RS 2005-10-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021906-002 KALETRA 100MG;25MG TABLET / ORAL AB RLD 2007-11-09 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
Observed Orange Book patent history# Patent history page 1 of 4 · 144 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021906-001 7148359 2019-07-19 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 7148359*PED 2020-01-19 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 7364752 2020-11-10 U-688 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 7364752*PED 2021-05-10 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8268349 2024-08-25 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8399015 2024-08-25 Drug product 2013-04-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8691878 2024-08-25 U-1513 2014-06-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8309613 2024-12-24 U-688 2012-12-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8268349*PED 2025-02-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8399015*PED 2025-02-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8691878*PED 2025-02-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8309613*PED 2025-06-24 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8470347 2026-09-17 Drug product 2013-07-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8470347*PED 2027-03-17 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8377952 2027-10-22 U-1372 2013-03-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8025899 2027-12-14 Drug product 2011-10-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8377952*PED 2028-04-22 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-001 8025899*PED 2028-06-14 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 7148359 2019-07-19 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 7148359*PED 2020-01-19 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 7364752 2020-11-10 U-688 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 7364752*PED 2021-05-10 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8268349 2024-08-25 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8399015 2024-08-25 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8691878 2024-08-25 U-1513 2014-06-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8309613 2024-12-24 U-688 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8268349*PED 2025-02-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8399015*PED 2025-02-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8691878*PED 2025-02-25 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8309613*PED 2025-06-24 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8470347 2026-09-17 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8470347*PED 2027-03-17 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8377952 2027-10-22 U-1372 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8025899 2027-12-14 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8377952*PED 2028-04-22 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021906-002 8025899*PED 2028-06-14 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021906-001 7148359 2019-07-19 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021906-001 7148359*PED 2020-01-19 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021906-001 7364752 2020-11-10 U-688 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021906-001 7364752*PED 2021-05-10 Pediatric extension 3f01610625f2…
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 · 49 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0074-0522 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-0522 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-0522 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-0522 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-0522 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-0522 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-0522 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-0522 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-0522 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-0522 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-1575 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-1575 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-1575 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-1575 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-1575 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-2605 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-2605 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-2605 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-2605 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-2605 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-6799 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-6799 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-6799 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-6799 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-6799 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-6799 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-6799 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-6799 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-6799 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 0074-6799 Kaletra Lopinavir and Ritonavir AbbVie Inc. NDA Current 11819-342 Kaletra Lopinavir and Ritonavir HHS/Program Support Center/Supply Service Center NDA Current 21695-362 Kaletra lopinavir and ritonavir Rebel Distributors Corp NDA Current 53808-0276 Kaletra lopinavir and ritonavir DOH CENTRAL PHARMACY NDA Current 55289-947 Kaletra Lopinavir and Ritonavir PD-Rx Pharmaceuticals, In NDA Current 55289-947 Kaletra Lopinavir and Ritonavir PD-Rx Pharmaceuticals, Inc. NDA Current 55289-947 Kaletra Lopinavir and Ritonavir PD-Rx Pharmaceuticals, Inc. NDA Current 55289-947 Kaletra Lopinavir and Ritonavir PD-Rx Pharmaceuticals, Inc. NDA Current 55289-947 Kaletra Lopinavir and Ritonavir PD-Rx Pharmaceuticals, Inc. NDA Current 55289-947 Kaletra Lopinavir and Ritonavir PD-Rx Pharmaceuticals, Inc. NDA Current 55289-947 Kaletra Lopinavir and Ritonavir PD-Rx Pharmaceuticals, Inc. NDA Current 66336-624 Kaletra Lopinavir and Ritonavir Dispensing Solutions, Inc. NDA Current 68071-2348 Kaletra Lopinavir and Ritonavir NuCare Pharmaceuticals,Inc. NDA Current 68258-1972 Kaletra Lopinavir and Ritonavir Dispensing Solutions, Inc. NDA Current 70518-0091 Kaletra Lopinavir and Ritonavir REMEDYREPACK INC. NDA Current 70518-0091 Kaletra Lopinavir and Ritonavir REMEDYREPACK INC. NDA Current 70518-0091 Kaletra Lopinavir and Ritonavir REMEDYREPACK INC. NDA Current 70518-0091 Kaletra Lopinavir and Ritonavir REMEDYREPACK INC. NDA Current 70518-0091 Kaletra Lopinavir and Ritonavir REMEDYREPACK INC. NDA Current 70518-0091 Kaletra Lopinavir and Ritonavir REMEDYREPACK INC. NDA Current