Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074553
Company: PHARM ASSOC
Company: PHARM ASSOC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CIMETIDINE HYDROCHLORIDE | CIMETIDINE HYDROCHLORIDE | EQ 300MG BASE/5ML | SOLUTION;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 |
---|---|---|---|---|---|---|---|
01/27/1997 | 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 |
---|---|---|---|---|---|
11/22/2021 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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10/07/2005 | SUPPL-4 | Labeling |
Label is not available on this site. |