FDA.reportPublic FDA data

Application 021076

Type
NDA
Sponsor
BAYER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALEVE-D SINUS & COLDNAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL220MG;120MGYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021076-001ALEVE-D SINUS & COLDNAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1999-11-29

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021076-001ALEVE-D SINUS & COLD220MG;120MGTABLET, EXTENDED RELEASE / ORALRLD1999-11-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021076-001ALEVE-D SINUS & COLD220MG;120MGTABLET, EXTENDED RELEASE / ORALRLD1999-11-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021076-001ALEVE-D SINUS & COLD220MG;120MGTABLET, EXTENDED RELEASE / ORALRLD1999-11-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021076-001ALEVE-D SINUS & COLD220MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1999-11-29a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74724SUPPL 2023-07-12
74723SUPPL 2023-07-12
70394SUPPL2022-03-03
70381SUPPL2022-03-03
62467SUPPL2020-04-07
62466SUPPL2020-04-07
49821SUPPL2017-09-21
49756SUPPL2017-09-15
26650SUPPL2009-04-21
26649SUPPL2008-08-06
26648SUPPL2006-01-20
23622ORIG2005-07-28
41930ORIG2004-05-26
4225SUPPL2002-07-31
14296ORIG1999-11-29
4224ORIG1999-11-29