Application 020919

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GEODONZIPRASIDONE MESYLATEINJECTABLE;INTRAMUSCULAREQ 20MG BASE/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020919-001GEODONZIPRASIDONE MESYLATEEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N020919-001AP

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARRLD, RS2002-06-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARAPRLD, RS2002-06-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARAPRLD, RS2002-06-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARAPRLD, RS2002-06-2187673890dc5c…
2021-03-12 10:30 UTC2021-03N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARAPRLD, RS2002-06-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARAPRLD, RS2002-06-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARAPRLD, RS2002-06-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARRLD, RS2002-06-213f01610625f2…
2019-09-15 20:21 UTC2019-09N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARRLD, RS2002-06-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARRLD, RS2002-06-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-213f0d92c62455…
2023-05-13 08:27 UTC2023-05N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21053a50430f4f…
2023-01-26 05:58 UTC2023-01N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020919-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020919-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020919-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020919-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020919-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020919-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020919-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020919-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020919-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020919-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020919-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020919-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020919-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020919-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020919-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020919-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020919-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N020919-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020919-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020919-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N020919-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020919-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020919-001AP1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020919-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020919-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020919-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020919-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020919-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020919-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020919-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020919-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020919-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020919-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020919-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020919-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020919-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020919-001AP1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GeodonZIPRASIDONEViatris Specialty LLCa2b4cc65-6a6d-49c4-adfc-a4458562a1672025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020919
application number: NDA020919
GeodonZIPRASIDONE HYDROCHLORIDEROERIG8326928a-2cb6-4f7f-9712-03a425a14c372025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020919
application number: NDA020919
ndc (product): 0049-3920

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0049-1203Geodonziprasidone mesylateRoerigNDACurrent
0049-1203Geodonziprasidone mesylateRoerigNDACurrent
0049-1203Geodonziprasidone mesylateRoerigNDACurrent
0049-1203Geodonziprasidone mesylateRoerigNDACurrent
0049-3920Geodonziprasidone mesylateRoerigNDACurrent
0049-3920Geodonziprasidone mesylateRoerigNDACurrent
0049-3920Geodonziprasidone mesylateRoerigNDACurrent
0049-3920Geodonziprasidone mesylateRoerigNDACurrent
0049-3920Geodonziprasidone mesylateRoerigNDACurrent
0049-3920Geodonziprasidone mesylateRoerigNDACurrent
0049-3920Geodonziprasidone mesylateRoerigNDACurrent
0049-3920Geodonziprasidone mesylateRoerigNDACurrent
0049-3920Geodonziprasidone mesylateRoerigNDACurrent
0049-3920Geodonziprasidone mesylateRoerigNDACurrent
50090-4540Geodonziprasidone mesylateA-S Medication SolutionsNDACurrent
50090-4540Geodonziprasidone mesylateA-S Medication SolutionsNDACurrent
50090-4540Geodonziprasidone mesylateA-S Medication SolutionsNDACurrent
50090-4540Geodonziprasidone mesylateA-S Medication SolutionsNDACurrent
64725-3920Geodonziprasidone mesylateTYA PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81063SUPPL 2025-02-06
80946SUPPL 2025-02-05
67561SUPPL2021-05-20
67552SUPPL2021-05-19
66067SUPPL2021-02-02
65116SUPPL2020-11-02
61643SUPPL2020-01-24
61634SUPPL2020-01-24
56500SUPPL2018-11-16
56315SUPPL2018-11-06
47419SUPPL2017-03-02
47313SUPPL2017-02-24
35648SUPPL2015-09-14
26203SUPPL2015-08-24
35647SUPPL2014-12-11
3752SUPPL2014-12-11
26202SUPPL2013-12-19
13741SUPPL2013-12-19
26201SUPPL2013-08-16
13740SUPPL2013-08-15
26199SUPPL2013-07-05
13739SUPPL2013-07-05
26200SUPPL2013-03-05
35646SUPPL2013-03-04
23610ORIG2011-12-22
26198SUPPL2010-12-07
35645SUPPL2010-12-04
26197SUPPL2009-08-04
35644SUPPL2009-07-21
26196SUPPL2008-12-24
3751SUPPL2008-08-19
21276SUPPL2008-07-30
26195SUPPL2008-05-21
35643SUPPL2007-10-04
3750SUPPL2007-10-04
26194SUPPL2007-05-29
13738SUPPL2007-05-29
35642SUPPL2007-03-07
26193SUPPL2007-03-07
35641SUPPL2005-08-19
26192SUPPL2005-08-19
13737SUPPL2005-08-19
3749SUPPL2005-08-19
41812ORIG2005-04-08
3748SUPPL2004-08-25
3747SUPPL2003-12-24
26191ORIG2002-06-21
13736ORIG2002-06-21