FDA.reportPublic FDA data

Application 020624

Type
NDA
Sponsor
US PHARM HOLDINGS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANZEMETDOLASETRON MESYLATEINJECTABLE;INJECTION100MG/5ML (20MG/ML)YesNo
002ANZEMETDOLASETRON MESYLATEINJECTABLE;INJECTION12.5MG/0.625ML (20MG/ML)YesNo
003ANZEMETDOLASETRON MESYLATEINJECTABLE;INJECTION500MG/25ML (20MG/ML)NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020624-001ANZEMETDOLASETRON MESYLATE100MG/5ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-11
N020624-002ANZEMETDOLASETRON MESYLATE12.5MG/0.625ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-11
N020624-003ANZEMETDOLASETRON MESYLATE500MG/25ML (20MG/ML)INJECTABLE / INJECTION2001-12-11

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020624-001ANZEMET100MG/5ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020624-002ANZEMET12.5MG/0.625ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020624-003ANZEMET500MG/25ML (20MG/ML)INJECTABLE / INJECTION2001-12-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020624-001ANZEMET100MG/5ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020624-002ANZEMET12.5MG/0.625ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020624-003ANZEMET500MG/25ML (20MG/ML)INJECTABLE / INJECTION2001-12-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020624-001ANZEMET100MG/5ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020624-002ANZEMET12.5MG/0.625ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020624-003ANZEMET500MG/25ML (20MG/ML)INJECTABLE / INJECTION2001-12-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020624-001ANZEMET100MG/5ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020624-002ANZEMET12.5MG/0.625ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020624-003ANZEMET500MG/25ML (20MG/ML)INJECTABLE / INJECTION2001-12-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020624-001ANZEMET100MG/5ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020624-002ANZEMET12.5MG/0.625ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020624-003ANZEMET500MG/25ML (20MG/ML)INJECTABLE / INJECTION2001-12-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020624-001ANZEMET100MG/5ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020624-002ANZEMET12.5MG/0.625ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020624-003ANZEMET500MG/25ML (20MG/ML)INJECTABLE / INJECTION2001-12-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020624-001ANZEMET100MG/5ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020624-002ANZEMET12.5MG/0.625ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020624-003ANZEMET500MG/25ML (20MG/ML)INJECTABLE / INJECTION2001-12-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020624-001ANZEMET100MG/5ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020624-002ANZEMET12.5MG/0.625ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020624-003ANZEMET500MG/25ML (20MG/ML)INJECTABLE / INJECTION2001-12-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020624-001ANZEMET100MG/5ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020624-002ANZEMET12.5MG/0.625ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020624-003ANZEMET500MG/25ML (20MG/ML)INJECTABLE / INJECTION2001-12-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020624-001ANZEMET100MG/5ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10N020624-002ANZEMET12.5MG/0.625ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10N020624-003ANZEMET500MG/25ML (20MG/ML)INJECTABLE / INJECTION2001-12-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020624-001ANZEMET100MG/5ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020624-002ANZEMET12.5MG/0.625ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020624-003ANZEMET500MG/25ML (20MG/ML)INJECTABLE / INJECTION2001-12-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020624-001ANZEMET100MG/5ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020624-002ANZEMET12.5MG/0.625ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020624-003ANZEMET500MG/25ML (20MG/ML)INJECTABLE / INJECTION2001-12-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020624-001ANZEMET100MG/5ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020624-002ANZEMET12.5MG/0.625ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020624-003ANZEMET500MG/25ML (20MG/ML)INJECTABLE / INJECTION2001-12-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020624-001ANZEMET100MG/5ML (20MG/ML)INJECTABLE / INJECTIONRLD1997-09-118072bd15b7f6…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
2900SUPPL2014-09-23
34973SUPPL2014-09-22
34972SUPPL2013-09-17
2899SUPPL2013-09-17
34971SUPPL2011-09-29
25339SUPPL2011-09-27
2898SUPPL2009-11-10
34970SUPPL2009-10-14
41488SUPPL2008-02-19
25338SUPPL2007-09-26
20769SUPPL2007-07-06
12861SUPPL2007-06-04
2897SUPPL2007-06-04
25337SUPPL2005-06-07
12860SUPPL2005-06-07
2896SUPPL2004-05-27
25336SUPPL2003-07-28
25335SUPPL2002-03-22
41487ORIG1998-10-20