Drugs@FDA: FDA-Approved Drugs
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | AB | No | No |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;25MG;160MG | TABLET;ORAL | Prescription | AB | No | No |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | AB | No | No |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;160MG | TABLET;ORAL | Prescription | AB | No | No |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;320MG | 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 |
---|---|---|---|---|---|---|---|
12/19/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/29/2023 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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03/11/2022 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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03/11/2022 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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03/16/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; EQ 5MG BASE;12.5MG;160MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | No | AB | 206180 | AUROBINDO PHARMA |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | No | AB | 200797 | LUPIN LTD |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | No | AB | 201087 | STRIDES PHARMA |
EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | Yes | AB | 022314 | NOVARTIS |
TABLET;ORAL; EQ 5MG BASE;25MG;160MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;25MG;160MG | TABLET;ORAL | Prescription | No | AB | 206180 | AUROBINDO PHARMA |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;25MG;160MG | TABLET;ORAL | Prescription | No | AB | 200797 | LUPIN LTD |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;25MG;160MG | TABLET;ORAL | Prescription | No | AB | 201087 | STRIDES PHARMA |
EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;25MG;160MG | TABLET;ORAL | Prescription | Yes | AB | 022314 | NOVARTIS |
TABLET;ORAL; EQ 10MG BASE;12.5MG;160MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | No | AB | 206180 | AUROBINDO PHARMA |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | No | AB | 200797 | LUPIN LTD |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | No | AB | 201087 | STRIDES PHARMA |
EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | Yes | AB | 022314 | NOVARTIS |
TABLET;ORAL; EQ 10MG BASE;25MG;160MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;160MG | TABLET;ORAL | Prescription | No | AB | 206180 | AUROBINDO PHARMA |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;160MG | TABLET;ORAL | Prescription | No | AB | 200797 | LUPIN LTD |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;160MG | TABLET;ORAL | Prescription | No | AB | 201087 | STRIDES PHARMA |
EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;160MG | TABLET;ORAL | Prescription | Yes | AB | 022314 | NOVARTIS |
TABLET;ORAL; EQ 10MG BASE;25MG;320MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;320MG | TABLET;ORAL | Prescription | No | AB | 206180 | AUROBINDO PHARMA |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;320MG | TABLET;ORAL | Prescription | No | AB | 200797 | LUPIN LTD |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;320MG | TABLET;ORAL | Prescription | No | AB | 201087 | STRIDES PHARMA |
EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;320MG | TABLET;ORAL | Prescription | Yes | AB | 022314 | NOVARTIS |