FDA.reportPublic FDA data

Application 021224

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAZADYNEGALANTAMINE HYDROBROMIDESOLUTION;ORAL4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

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
N021224-001RAZADYNEGALANTAMINE HYDROBROMIDE4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORAL2001-06-22

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 UTC2022-10N021224-001RAZADYNE4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORAL2001-06-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021224-001RAZADYNE4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORAL2001-06-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021224-001RAZADYNE4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORAL2001-06-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021224-001RAZADYNE4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORAL2001-06-22a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Galantamine HydrobromideGALANTAMINE HYDROBROMIDEBryant Ranch Prepack0f74a146-f6ee-4910-82a3-177153526dd02025-09-12Warnings, Adverse reactionsName fallback
generic name: GALANTAMINE HYDROBROMIDE
Galantamine HydrobromideGALANTAMINE HYDROBROMIDEBryant Ranch Prepack3059d10f-fb3d-4cbd-b936-104608889b672024-08-12Warnings, Adverse reactionsName fallback
generic name: GALANTAMINE HYDROBROMIDE
Galantamine HydrobromideGALANTAMINE HYDROBROMIDEBryant Ranch Prepackdb5b6c1e-449b-413f-b0cc-ca2133aa49862024-08-12Warnings, Adverse reactionsName fallback
generic name: GALANTAMINE HYDROBROMIDE
Galantamine HydrobromideGALANTAMINE HYDROBROMIDEBryant Ranch Prepack3e7e2839-a834-4464-a82a-7554e10ad0042024-08-12Warnings, Adverse reactionsName fallback
generic name: GALANTAMINE HYDROBROMIDE
Galantamine HydrobromideGALANTAMINE HYDROBROMIDEBryant Ranch Prepack5cd99bc0-0f18-4800-a0f5-a94eebf0eead2024-04-08Warnings, Adverse reactionsName fallback
generic name: GALANTAMINE HYDROBROMIDE
Galantamine HydrobromideGALANTAMINE HYDROBROMIDEBryant Ranch Prepackc44108aa-bf20-4d45-b36f-d117320a675b2024-04-08Warnings, Adverse reactionsName fallback
generic name: GALANTAMINE HYDROBROMIDE
Galantamine HydrobromideGALANTAMINE HYDROBROMIDESun Pharmaceutical Industries, Inc.d1697161-ebe8-42b0-83e7-c9de4412546c2023-10-26Warnings, Adverse reactionsName fallback
generic name: GALANTAMINE HYDROBROMIDE
Galantamine HydrobromideGALANTAMINE HYDROBROMIDEHikma Pharmaceuticals USA Inc.d5b0e225-e94d-4324-afb2-b6e51c949dd02023-10-25Warnings, Adverse reactionsName fallback
generic name: GALANTAMINE HYDROBROMIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47241SUPPL2017-02-16
47238SUPPL2017-02-16
27112SUPPL2015-12-17
14665SUPPL2015-12-17
4676SUPPL2015-02-12
36385SUPPL2015-02-10
14664SUPPL2013-07-11
4674SUPPL2013-07-02
36384SUPPL2012-05-01
36383SUPPL2012-03-06
14663SUPPL2012-03-06
27111SUPPL2012-03-05
4675SUPPL2012-03-05
4673SUPPL2012-03-05
27110SUPPL2006-05-01
27109SUPPL2006-05-01
4672SUPPL2006-05-01
4671SUPPL2006-05-01
23635ORIG2005-07-29
4670SUPPL2005-05-03
4669SUPPL2003-09-09
4668SUPPL2002-05-02
21518ORIG2002-03-05
14662ORIG2001-06-22
4667ORIG2001-06-22