FDA.reportPublic FDA data

Application 021483

Type
NDA
Sponsor
PFIZER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GEODONZIPRASIDONE HYDROCHLORIDESUSPENSION;ORALEQ 10MG BASE/MLNoNo

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
N021483-001GEODONZIPRASIDONE HYDROCHLORIDEEQ 10MG BASE/MLSUSPENSION / ORAL2006-03-29

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 UTC2022-10N021483-001GEODONEQ 10MG BASE/MLSUSPENSION / ORAL2006-03-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021483-001GEODONEQ 10MG BASE/MLSUSPENSION / ORAL2006-03-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021483-001GEODONEQ 10MG BASE/MLSUSPENSION / ORAL2006-03-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021483-001GEODONEQ 10MG BASE/MLSUSPENSION / ORAL2006-03-29a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021483-00161503662019-05-27U-719Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021483-00171758552020-05-18Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021483-00171758552020-05-18Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021483-00171758552020-05-18Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021483-00161503662019-05-27U-719Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021483-00171758552020-05-18Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021483-00161503662019-05-27U-719Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021483-00171758552020-05-18Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021483-00161503662019-05-27U-719Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021483-00171758552020-05-18Drug productea99ee380514…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack5d576819-cd14-4a61-8a2f-6b90d8eac07e2026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEREMEDYREPACK INC.c9f8f635-cf3f-4c42-8bd1-45bbe19bf97e2026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEREMEDYREPACK INC.a66a0b25-673c-4a3d-b923-5f65a02b8ff02026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEREMEDYREPACK INC.4e7e2d5d-8ea8-4c25-a500-f4794542fda22026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack14191e0d-8219-4f6e-b808-09c4804a82622026-03-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack7c683604-b827-434d-aff3-ee2ed0565cd72026-03-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEAurobindo Pharma Limitedcc5e1c44-79e9-45d3-b1e5-b003f550c5082025-05-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEBluePoint Laboratoriesc0eb7b4d-0264-4eed-8756-51bba3af82fb2025-04-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.fc9ffbc3-1f16-9265-e053-6294a90acfd22025-02-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEA-S Medication Solutionsc3797145-cead-4fc4-9711-8b8623bb09f42024-11-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack550aca3a-5051-432e-9a3f-a2e53cbd603d2024-04-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.0fcebd61-25b2-d287-e063-6394a90a7b9a2024-01-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack798631b6-b9d9-44de-9a1a-ae2cee86d5312023-11-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepackfa70291d-8455-40d6-9b73-bf91880f99792023-10-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack48e6e141-66d3-4eab-b0bf-dfd1d44b48322023-09-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone HydrochlorideZIPRASIDONE HYDROCHLORIDEMacleods Pharmaceuticals Limited3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af02023-02-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ZIPRASIDONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47418SUPPL2017-03-02
47312SUPPL2017-02-24
15574SUPPL2015-09-14
5510SUPPL2015-08-24
27905SUPPL2014-12-11
15573SUPPL2014-12-11
5509SUPPL2013-08-16
15572SUPPL2013-08-15
37045SUPPL2013-07-05
27903SUPPL2013-07-05
27904SUPPL2013-03-05
37046SUPPL2013-03-04
27902SUPPL2010-12-07
15571SUPPL2010-12-04
5508SUPPL2009-11-24
15570SUPPL2009-09-18
42190ORIG2007-06-29
23666ORIG2006-04-05
5507ORIG2006-04-05