Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017854
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| REGLAN | METOCLOPRAMIDE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
| REGLAN | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/09/2026 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/017854s071lbl.pdf | |
| 08/29/2017 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017854s062lbl.pdf | |
| 09/22/2011 | SUPPL-58 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017854s058lbl.pdf | |
| 11/18/2010 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017854s055lbl.pdf | |
| 09/04/2009 | SUPPL-52 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s052lbl.pdf | |
| 09/04/2009 | SUPPL-52 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s052lbl.pdf | |
| 06/30/2009 | SUPPL-51 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s051,021793s004lbl.pdf | |
| 07/26/2004 | SUPPL-47 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17854s047lbl.pdf |