FDA.reportPublic FDA data

Application 022246

Type
NDA
Sponsor
SALIX PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOZOLV ODTMETOCLOPRAMIDE HYDROCHLORIDETABLET, ORALLY DISINTEGRATING;ORALEQ 5MG BASEYesNo
002METOZOLV ODTMETOCLOPRAMIDE HYDROCHLORIDETABLET, ORALLY DISINTEGRATING;ORALEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022246-001METOZOLV ODTMETOCLOPRAMIDE HYDROCHLORIDEEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2009-09-04
N022246-002METOZOLV ODTMETOCLOPRAMIDE HYDROCHLORIDEEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2009-09-04

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 3 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N022246-001METOZOLV ODTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2009-09-04e64feba35796…
2022-09-29 23:25 UTC2022-09N022246-002METOZOLV ODTEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2009-09-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022246-001METOZOLV ODTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2009-09-04cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022246-002METOZOLV ODTEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2009-09-04cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022246-001METOZOLV ODTEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2009-09-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022246-002METOZOLV ODTEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, ORALLY DISINTEGRATING / ORALRLD2009-09-04a50c72e98297…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.3cd4b274-6176-4e5b-9765-4f50763bd58f2026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEAvenacy, LLCdc4a13f8-1e9b-4c75-82c0-bcd11f0a9a662026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
METOCLOPRAMIDEMETOCLOPRAMIDE HYDROCHLORIDEHenry Schein, Inc.f50c8fb4-23c4-4762-95bb-e4ca7b289a4d2026-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.50a3cf38-66dc-4fa5-8a45-adf959c987ab2026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
GIMOTIMETOCLOPRAMIDE HYDROCHLORIDEEvoke Pharma, Inc.95269b1f-779c-4ca0-9f86-e74e677f99002026-02-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
ReglanMETOCLOPRAMIDE HYDROCHLORIDEANI Pharmaceuticals, Inc.de55c133-eb08-4a35-91a2-5dc0930273972026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
metoclopramide hydrochlorideMETOCLOPRAMIDE HYDROCHLORIDEChartwell RX, LLCdc364325-dd39-4259-a348-3760eccdca4b2026-02-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
metoclopramide hydrochlorideMETOCLOPRAMIDE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.c4ab34f2-25e6-47bd-9dde-1f4baf469f0d2025-11-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma3cc8ca5b-8b71-4c77-a181-9ce154597b9a2024-11-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEGenus Lifesciences Inc.74358569-7a24-4a59-a7fc-500d2341d6cb2024-05-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEFresenius Kabi USA, LLCcc739885-e10e-4bcb-a781-c726c518f3d12023-06-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
MetoclopramideMETOCLOPRAMIDE HYDROCHLORIDEMedical Purchasing Solutions, LLCd163182b-582d-df59-e053-2995a90a300b2023-05-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE HYDROCHLORIDE
METOCLOPRAMIDE hydrochlorideMETOCLOPRAMIDE HYDROCHLORIDELupin Pharmaceuticals,Inc.7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa2020-12-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOCLOPRAMIDE 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
57913SUPPL2019-03-06
57912SUPPL2019-03-06
57859SUPPL2019-03-01
38416SUPPL2011-09-30
7081SUPPL2011-09-29
7080SUPPL2011-09-06
29436SUPPL2010-11-22
38415SUPPL2010-11-18
44713ORIG2010-03-30
42460ORIG2010-03-30
23369ORIG2009-10-19
17112ORIG2009-09-18
7079ORIG2009-09-09