Application 022246
- Type
- NDA
- Sponsor
- SALIX PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METOZOLV ODT | METOCLOPRAMIDE HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 5MG BASE | Yes | No |
| 002 | METOZOLV ODT | METOCLOPRAMIDE HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022246-001 | METOZOLV ODT | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | |
| N022246-002 | METOZOLV ODT | METOCLOPRAMIDE HYDROCHLORIDE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022246-001 | METOZOLV ODT | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022246-001 | METOZOLV ODT | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022246-001 | METOZOLV ODT | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022246-001 | METOZOLV ODT | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022246-001 | METOZOLV ODT | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022246-001 | METOZOLV ODT | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022246-001 | METOZOLV ODT | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022246-001 | METOZOLV ODT | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022246-001 | METOZOLV ODT | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022246-001 | METOZOLV ODT | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022246-001 | METOZOLV ODT | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022246-001 | METOZOLV ODT | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022246-001 | METOZOLV ODT | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022246-001 | METOZOLV ODT | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022246-001 | METOZOLV ODT | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022246-001 | METOZOLV ODT | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022246-002 | METOZOLV ODT | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022246-001 | METOZOLV ODT | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022246-002 | METOZOLV ODT | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022246-001 | METOZOLV ODT | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022246-001 | METOZOLV ODT | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022246-001 | METOZOLV ODT | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022246-002 | METOZOLV ODT | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2009-09-04 | 782e0a99824c… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Metoclopramide | METOCLOPRAMIDE HYDROCHLORIDE | ATLANTIC BIOLOGICALS CORP. | 3cd4b274-6176-4e5b-9765-4f50763bd58f | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | METOCLOPRAMIDE HYDROCHLORIDE |
| Metoclopramide | METOCLOPRAMIDE HYDROCHLORIDE | Avenacy, LLC | dc4a13f8-1e9b-4c75-82c0-bcd11f0a9a66 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | METOCLOPRAMIDE HYDROCHLORIDE |
| METOCLOPRAMIDE | METOCLOPRAMIDE HYDROCHLORIDE | Henry Schein, Inc. | f50c8fb4-23c4-4762-95bb-e4ca7b289a4d | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | METOCLOPRAMIDE HYDROCHLORIDE |
| Metoclopramide | METOCLOPRAMIDE HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 50a3cf38-66dc-4fa5-8a45-adf959c987ab | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | METOCLOPRAMIDE HYDROCHLORIDE |
| GIMOTI | METOCLOPRAMIDE HYDROCHLORIDE | Evoke Pharma, Inc. | 95269b1f-779c-4ca0-9f86-e74e677f9900 | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | METOCLOPRAMIDE HYDROCHLORIDE |
| Reglan | METOCLOPRAMIDE HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | de55c133-eb08-4a35-91a2-5dc093027397 | 2026-02-09 | Boxed warning, Warnings, Adverse reactions | METOCLOPRAMIDE HYDROCHLORIDE |
| metoclopramide hydrochloride | METOCLOPRAMIDE HYDROCHLORIDE | Chartwell RX, LLC | dc364325-dd39-4259-a348-3760eccdca4b | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | METOCLOPRAMIDE HYDROCHLORIDE |
| metoclopramide hydrochloride | METOCLOPRAMIDE HYDROCHLORIDE | Chartwell Governmental & Specialty RX, LLC. | c4ab34f2-25e6-47bd-9dde-1f4baf469f0d | 2025-11-12 | Boxed warning, Warnings, Adverse reactions | METOCLOPRAMIDE HYDROCHLORIDE |
| Metoclopramide | METOCLOPRAMIDE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 3cc8ca5b-8b71-4c77-a181-9ce154597b9a | 2024-11-13 | Boxed warning, Warnings, Adverse reactions | METOCLOPRAMIDE HYDROCHLORIDE |
| Metoclopramide | METOCLOPRAMIDE HYDROCHLORIDE | Genus Lifesciences Inc. | 74358569-7a24-4a59-a7fc-500d2341d6cb | 2024-05-28 | Boxed warning, Warnings, Adverse reactions | METOCLOPRAMIDE HYDROCHLORIDE |
| Metoclopramide | METOCLOPRAMIDE HYDROCHLORIDE | Fresenius Kabi USA, LLC | cc739885-e10e-4bcb-a781-c726c518f3d1 | 2023-06-07 | Boxed warning, Warnings, Adverse reactions | METOCLOPRAMIDE HYDROCHLORIDE |
| Metoclopramide | METOCLOPRAMIDE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | d163182b-582d-df59-e053-2995a90a300b | 2023-05-02 | Boxed warning, Warnings, Adverse reactions | METOCLOPRAMIDE HYDROCHLORIDE |
| METOCLOPRAMIDE hydrochloride | METOCLOPRAMIDE HYDROCHLORIDE | Lupin Pharmaceuticals,Inc. | 7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa | 2020-12-02 | Boxed warning, Warnings, Adverse reactions | METOCLOPRAMIDE HYDROCHLORIDE |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57913 | SUPPL | 2019-03-06 |
| 57912 | SUPPL | 2019-03-06 |
| 57859 | SUPPL | 2019-03-01 |
| 38416 | SUPPL | 2011-09-30 |
| 7081 | SUPPL | 2011-09-29 |
| 7080 | SUPPL | 2011-09-06 |
| 29436 | SUPPL | 2010-11-22 |
| 38415 | SUPPL | 2010-11-18 |
| 44713 | ORIG | 2010-03-30 |
| 42460 | ORIG | 2010-03-30 |
| 23369 | ORIG | 2009-10-19 |
| 17112 | ORIG | 2009-09-18 |
| 7079 | ORIG | 2009-09-09 |