Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206180
Company: AUROBINDO PHARMA
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-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/11/2022 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/11/2022 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 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 |