Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075000
Company: RANBAXY
Company: RANBAXY
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 |
---|---|---|---|---|---|---|---|
01/30/1998 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75000ap.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/14/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
04/22/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |