Home Applications 020021 Application 020021
Type NDA
Sponsor J AND J CONSUMER INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 SUDAFED 24 HOUR PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 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 N020021-002 SUDAFED 24 HOUR PSEUDOEPHEDRINE HYDROCHLORIDE 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 1992-12-15
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 N020021-002 SUDAFED 24 HOUR 240MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 1992-12-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020021-002 SUDAFED 24 HOUR 240MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 1992-12-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020021-002 SUDAFED 24 HOUR 240MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 1992-12-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020021-002 SUDAFED 24 HOUR 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 1992-12-15 a50c72e98297…
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 2 · 35 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 50580-240 Sudafed Sinus Congestion 24 Hour Pseudoephedrine Hydrochloride Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division NDA Current 50580-240 Sudafed Sinus Congestion 24 Hour Pseudoephedrine Hydrochloride Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division NDA Current 50580-240 Sudafed Sinus Congestion 24 Hour Pseudoephedrine Hydrochloride Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division NDA Current 50580-669 Sudafed Pseudoephedrine Hydrochloride Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division NDA Current 50580-669 Sudafed Pseudoephedrine Hydrochloride Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division NDA Current 50580-669 Sudafed Pseudoephedrine Hydrochloride Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 56680 SUPPL 2018-12-07 56482 SUPPL 2018-11-23 41121 SUPPL 2007-07-06 20451 SUPPL 2007-07-06 20450 SUPPL 2007-07-06 41120 SUPPL 2007-05-09 20449 SUPPL 2007-05-09 20448 SUPPL 2007-05-09