Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077824
Company: AMNEAL PHARMS NY
Company: AMNEAL PHARMS NY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 300MG 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 |
|---|---|---|---|---|---|---|---|
| 10/13/2006 | 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 |
|---|---|---|---|---|---|
| 02/07/2017 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/20/2008 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |