Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074552
Company: MYLAN
Company: MYLAN
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 |
---|---|---|---|---|---|---|---|
07/30/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74552ltr.pdf |