Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078374
Company: NORTHSTAR HLTHCARE
Company: NORTHSTAR HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/30/2007 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/30/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/19/2013 | SUPPL-7 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/19/2013 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/28/2011 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078374Orig1s005.pdf |
| 02/28/2011 | SUPPL-4 | Labeling-Medication Guide, Labeling-Container/Carton Labels |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078374Orig1s004.pdf |
| 03/30/2010 | SUPPL-3 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/078374Orig1s003.pdf |