Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076195
Company: PERRIGO
Company: PERRIGO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Over-the-counter | 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 |
---|---|---|---|---|---|---|---|
08/30/2002 | 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 |
---|---|---|---|---|---|
01/24/2018 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
02/05/2016 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
RANITIDINE HYDROCHLORIDE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; EQ 75MG BASE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Over-the-counter | No | 207579 | AUROBINDO PHARMA LTD |
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Over-the-counter | No | 075294 | DR REDDYS LABS LTD |
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Over-the-counter | No | 076195 | PERRIGO |
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Over-the-counter | No | 210250 | UNIQUE PHARM LABS |
ZANTAC 75 | RANITIDINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Over-the-counter | Yes | 020520 | SANOFI US |
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