Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077405
Company: PHARM ASSOC
Company: PHARM ASSOC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 15MG BASE/ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 09/21/2007 | 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 |
|---|---|---|---|---|---|
| 10/27/2010 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/28/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |