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 | CAPSULE;ORAL | Prescription | AB | No | No |
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/22/1997 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/74655_Ranitidine.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/07/2013 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
05/27/2009 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
12/26/2007 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
04/28/2005 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
03/12/2004 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
04/19/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/06/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/19/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/26/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/30/2000 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/25/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
03/03/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
02/02/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/09/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/20/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/20/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
RANITIDINE HYDROCHLORIDE
CAPSULE;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 | CAPSULE;ORAL | Prescription | No | AB | 075742 | DR REDDYS LABS LTD |
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074655 | SANDOZ |
CAPSULE;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 | CAPSULE;ORAL | Prescription | No | AB | 075742 | DR REDDYS LABS LTD |
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074655 | SANDOZ |