Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040702
Company: LEADING
Company: LEADING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | AB | No | No |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | 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 |
---|---|---|---|---|---|---|---|
03/16/2007 | 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 |
---|---|---|---|---|---|
10/06/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
08/20/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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10/22/2014 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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05/01/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
HYDROCHLOROTHIAZIDE
TABLET;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 202556 | ACCORD HLTHCARE |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040780 | AUROBINDO PHARMA |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 085182 | HERITAGE |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040807 | IPCA LABS LTD |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 083177 | IVAX SUB TEVA PHARMS |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040702 | LEADING |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 087059 | OXFORD PHARMS |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 203018 | SCIEGEN PHARMS INC |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040907 | UNICHEM |
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 202556 | ACCORD HLTHCARE |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040780 | AUROBINDO PHARMA |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 085182 | HERITAGE |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040807 | IPCA LABS LTD |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 083177 | IVAX SUB TEVA PHARMS |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040702 | LEADING |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 087068 | OXFORD PHARMS |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 203018 | SCIEGEN PHARMS INC |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040907 | UNICHEM |
TABLET;ORAL; 12.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 202556 | ACCORD HLTHCARE |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 040707 | ACTAVIS ELIZABETH |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 085182 | HERITAGE |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 040807 | IPCA LABS LTD |
HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 040702 | LEADING |