Home Applications 021605 Application 021605
Type NDA
Sponsor MERCK SHARP DOHME Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLARINEX D 24 HOUR DESLORATADINE; PSEUDOEPHEDRINE SULFATE TABLET, EXTENDED RELEASE;ORAL 5MG;240MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N021605-001 CLARINEX D 24 HOUR DESLORATADINE; PSEUDOEPHEDRINE SULFATE 5MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 2005-03-03
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 2 of 2 · 44 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 2022-10-28 04:53 UTC 2022-10 N021605-001 CLARINEX D 24 HOUR 5MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 2005-03-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021605-001 CLARINEX D 24 HOUR 5MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 2005-03-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021605-001 CLARINEX D 24 HOUR 5MG;240MG TABLET, EXTENDED RELEASE / ORAL RLD 2005-03-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021605-001 CLARINEX D 24 HOUR 5MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 2005-03-03 a50c72e98297…
Observed Orange Book normalized TE history# 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 N021605-001 6979463 2022-03-28 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021605-001 7820199 2022-03-28 Drug product 2010-11-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021605-001 7820199*PED 2022-09-28 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021605-001 6979463 2022-03-28 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021605-001 7820199 2022-03-28 Drug product 2010-11-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021605-001 7820199*PED 2022-09-28 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021605-001 6979463 2022-03-28 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021605-001 7820199 2022-03-28 Drug product 2010-11-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021605-001 7820199*PED 2022-09-28 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021605-001 6100274 2019-07-07 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021605-001 6100274*PED 2020-01-07 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021605-001 7618649 2020-12-19 U-1017 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021605-001 7618649*PED 2021-06-19 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021605-001 6979463 2022-03-28 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021605-001 7820199 2022-03-28 Drug product 2010-11-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021605-001 7820199*PED 2022-09-28 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021605-001 6979463 2022-03-28 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021605-001 7820199 2022-03-28 Drug product 2010-11-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021605-001 7820199*PED 2022-09-28 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021605-001 7618649*PED 2021-06-19 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021605-001 6979463 2022-03-28 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021605-001 7820199 2022-03-28 Drug product 2010-11-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021605-001 7820199*PED 2022-09-28 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021605-001 7618649*PED 2021-06-19 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021605-001 6979463 2022-03-28 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021605-001 7820199 2022-03-28 Drug product 2010-11-23 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021605-001 7820199*PED 2022-09-28 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021605-001 7618649*PED 2021-06-19 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021605-001 6979463 2022-03-28 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021605-001 7820199 2022-03-28 Drug product 2010-11-23 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021605-001 7820199*PED 2022-09-28 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021605-001 6100274*PED 2020-01-07 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021605-001 7618649 2020-12-19 U-1017 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021605-001 7618649*PED 2021-06-19 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021605-001 6979463 2022-03-28 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021605-001 7820199 2022-03-28 Drug product 2010-11-23 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021605-001 7820199*PED 2022-09-28 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021605-001 6100274*PED 2020-01-07 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021605-001 7618649 2020-12-19 U-1017 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021605-001 7618649*PED 2021-06-19 Pediatric extension c0c555d07b60…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 58024 SUPPL 2019-03-18 58018 SUPPL 2019-03-18 53781 SUPPL 2018-04-23 53751 SUPPL 2018-04-20 52818 SUPPL 2018-03-06 52787 SUPPL 2018-03-01 15862 SUPPL 2014-03-10 5835 SUPPL 2014-03-10 37329 SUPPL 2010-01-12 5834 SUPPL 2010-01-05 42230 ORIG 2007-05-09 37328 ORIG 2005-03-10 5833 ORIG 2005-03-10