Application 020919

Type
NDA
Sponsor
PFIZER

Application Products#

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

NDC Listings For This Application#

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