METOCLOPRAMIDE HYDROCHLORIDE | A204756 | AVET LIFESCIENCES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Corporate Social Responsibility Advocate (Reprieve) - Citizen Petition FDA-2013-P-0990 · 3 docket documents Reprieve, a legal action charity, filed this citizen petition under 21 CFR 10.30 and sections 355, 355-1, 372, and 393 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA suspend approval of Reglan (metoclopramide) manufactured by ANI Pharmaceuticals, Inc. for use in force-feeding de | Other | 2013-09-04 | Open | — |
Citizen Petition from International Medication Systems Limited FDA-1987-P-0413 · 3 docket documents International Medication Systems Limited filed this citizen petition requesting that the FDA determine an abbreviated new drug application is acceptable for Metoclopramide Injection, Reglan®, at a new concentration of 1 mg/mL to replace the currently marketed 5 mg/mL formulation. The petitioner argu | Other | 2009-10-22 | Denied | International Medication Systems Limited |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2004-P-0480 · 3 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA declare metoclopramide hydrochloride orally disintegrating tablets in 5 mg and 10 mg strengths suitable for submission in an ANDA, using the reference listed drug Reglan tablets approved under | Other | 2009-10-22 | Open | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.5249
per ml
Lowest NADAC/Unit
$0.5249
per ml
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 23155024041METOCLOPRAMIDE 10 MG/2 ML VIAL | $0.5249 | ML | Generic | — | 2026-06-17 |
| 83634077902METOCLOPRAMIDE 10 MG/2 ML VIAL | $0.5249 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.