Home Applications 208984 Application 208984
Type NDA
Sponsor VIIV HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SELZENTRY MARAVIROC SOLUTION;ORAL 20MG/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 N208984-001 SELZENTRY MARAVIROC 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04
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 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208984-001 SELZENTRY 20MG/ML SOLUTION / ORAL RLD, RS 2016-11-04 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 2 · 79 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208984-001 6667314*PED 2022-02-06 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208984-001 7368460 2022-11-25 U-824 2016-11-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208984-001 7368460*PED 2023-05-25 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208984-001 6667314*PED 2022-02-06 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208984-001 7368460 2022-11-25 U-824 2016-11-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208984-001 7368460*PED 2023-05-25 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208984-001 6667314*PED 2022-02-06 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208984-001 7368460 2022-11-25 U-824 2016-11-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208984-001 7368460*PED 2023-05-25 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208984-001 6586430 2019-12-01 U-824 Drug substance, Drug product 2016-11-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208984-001 7576097 2021-05-25 Drug substance 2016-10-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208984-001 6667314 2021-08-06 U-824 Drug substance, Drug product 2016-11-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208984-001 7368460 2022-11-25 U-824 2016-11-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208984-001 6667314*PED 2022-02-06 Pediatric extension bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N208984-001 7368460 2022-11-25 U-824 2016-11-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N208984-001 7368460*PED 2023-05-25 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208984-001 7576097 2021-05-25 Drug substance 2016-10-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N208984-001 6667314 2021-08-06 U-824 Drug substance, Drug product 2016-11-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N208984-001 7576097*PED 2021-11-25 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N208984-001 6667314*PED 2022-02-06 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N208984-001 7368460 2022-11-25 U-824 2016-11-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N208984-001 7368460*PED 2023-05-25 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208984-001 7576097 2021-05-25 Drug substance 2016-10-23 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208984-001 6667314 2021-08-06 U-824 Drug substance, Drug product 2016-11-23 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208984-001 7576097*PED 2021-11-25 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208984-001 6667314*PED 2022-02-06 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208984-001 7368460 2022-11-25 U-824 2016-11-23 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208984-001 7368460*PED 2023-05-25 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208984-001 7576097 2021-05-25 Drug substance 2016-10-23 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N208984-001 6667314 2021-08-06 U-824 Drug substance, Drug product 2016-11-23 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N208984-001 7576097*PED 2021-11-25 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N208984-001 6667314*PED 2022-02-06 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N208984-001 7368460 2022-11-25 U-824 2016-11-23 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N208984-001 7368460*PED 2023-05-25 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208984-001 7576097 2021-05-25 Drug substance 2016-10-23 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N208984-001 6667314 2021-08-06 U-824 Drug substance, Drug product 2016-11-23 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N208984-001 7576097*PED 2021-11-25 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N208984-001 6667314*PED 2022-02-06 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N208984-001 7368460 2022-11-25 U-824 2016-11-23 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N208984-001 7368460*PED 2023-05-25 Pediatric extension 8869cabd3fbd…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 61 observed states.
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 · 13 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49702-237 SELZENTRY maraviroc ViiV Healthcare Company NDA Current 49702-237 SELZENTRY maraviroc ViiV Healthcare Company NDA Current 49702-237 SELZENTRY maraviroc ViiV Healthcare Company NDA Current 49702-237 SELZENTRY maraviroc ViiV Healthcare Company NDA Current 49702-237 SELZENTRY maraviroc ViiV Healthcare Company NDA Current 49702-237 SELZENTRY maraviroc ViiV Healthcare Company NDA Current 49702-237 SELZENTRY maraviroc ViiV Healthcare Company NDA Current 49702-237 SELZENTRY maraviroc ViiV Healthcare Company NDA Current 49702-260 SELZENTRY maraviroc ViiV Healthcare Company NDA Current 49702-260 SELZENTRY maraviroc ViiV Healthcare Company NDA Current 49702-260 SELZENTRY maraviroc ViiV Healthcare Company NDA Current 49702-260 SELZENTRY maraviroc ViiV Healthcare Company NDA Current 49702-260 SELZENTRY maraviroc ViiV Healthcare Company NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 65141 SUPPL 2020-11-03 65140 SUPPL 2020-11-03 65129 SUPPL 2020-11-03 54933 SUPPL 2018-07-20 54918 SUPPL 2018-07-19 54917 SUPPL 2018-07-19 50200 ORIG 2017-10-26 45861 ORIG 2016-11-09 45847 ORIG 2016-11-08 51324 ORIG 1900-01-01 51323 ORIG 1900-01-01