Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091429
Company: PERRIGO R AND D
Company: PERRIGO R AND D
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Over-the-counter | None | No | No |
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG 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 |
---|---|---|---|---|---|---|---|
05/11/2011 | ORIG-1 | Approval |
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 150MG BASE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Over-the-counter | No | 207578 | AUROBINDO PHARMA LTD |
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Over-the-counter | No | 078192 | DR REDDYS LABS LTD |
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Over-the-counter | No | 091429 | PERRIGO R AND D |
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Over-the-counter | No | 210228 | UNIQUE PHARM LABS |
ZANTAC 150 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Over-the-counter | Yes | 021698 | SANOFI US |
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 150MG BASE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Over-the-counter | No | 207578 | AUROBINDO PHARMA LTD |
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Over-the-counter | No | 078192 | DR REDDYS LABS LTD |
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Over-the-counter | No | 091429 | PERRIGO R AND D |
RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Over-the-counter | No | 210228 | UNIQUE PHARM LABS |
ZANTAC 150 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET;ORAL | Over-the-counter | Yes | 021698 | SANOFI US |
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