Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 08/29/1997 | ORIG-1 | Approval |
Review
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074467_ranitidine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/074467.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/07/2013 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/27/2009 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 12/26/2007 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 04/28/2005 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 11/05/2002 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/19/2002 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/2001 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/07/2000 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/25/2000 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 03/08/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/09/2000 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/18/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/23/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
RANITIDINE HYDROCHLORIDE
TABLET;ORAL; EQ 150MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 074680 | APOTEX |
| RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 076705 | DR REDDYS LABS INC |
| RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 078542 | GLENMARK PHARMS INC |
| RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 074467 | SANDOZ |
| RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 211289 | VKT PHARMA |
TABLET;ORAL; EQ 300MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 074680 | APOTEX |
| RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 076705 | DR REDDYS LABS INC |
| RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 078542 | GLENMARK PHARMS INC |
| RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 074467 | SANDOZ |
| RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 211289 | VKT PHARMA |