Home Applications 022116 Application 022116
Type NDA
Sponsor VIIV HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LEXIVA FOSAMPRENAVIR CALCIUM SUSPENSION;ORAL EQ 50MG BASE/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N022116-001 LEXIVA FOSAMPRENAVIR CALCIUM EQ 50MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUSPENSION / ORAL RLD 2007-06-14
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 · 41 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 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD 2007-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD 2007-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD 2007-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD 2007-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD 2007-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD 2007-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD 2007-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD 2007-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD 2007-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD 2007-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD 2007-06-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD 2007-06-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD 2007-06-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD 2007-06-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD 2007-06-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD 2007-06-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022116-001 LEXIVA EQ 50MG BASE/ML SUSPENSION / ORAL RLD, RS 2007-06-14 cb3db0bc1861…
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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49702-208 LEXIVA fosamprenavir calcium ViiV Healthcare Company NDA Current 49702-208 LEXIVA fosamprenavir calcium ViiV Healthcare Company NDA Current 49702-208 LEXIVA fosamprenavir calcium ViiV Healthcare Company NDA Current 49702-208 LEXIVA fosamprenavir calcium ViiV Healthcare Company NDA Current 49702-208 LEXIVA fosamprenavir calcium ViiV Healthcare Company NDA Current 49702-208 LEXIVA fosamprenavir calcium ViiV Healthcare Company NDA Current 49702-208 LEXIVA fosamprenavir calcium ViiV Healthcare Company NDA Current 49702-208 LEXIVA fosamprenavir calcium ViiV Healthcare Company NDA Current 49702-208 LEXIVA fosamprenavir calcium ViiV Healthcare Company NDA Current