Drugs@FDA: FDA-Approved Drugs
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 12.5MG;EQ 10MG BASE | TABLET;ORAL | Prescription | AB | No | No |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 12.5MG;EQ 20MG BASE | TABLET;ORAL | Prescription | AB | No | No |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 25MG;EQ 20MG BASE | 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 |
---|---|---|---|---|---|---|---|
03/12/2013 | 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 |
---|---|---|---|---|---|
05/27/2022 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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05/27/2022 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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05/27/2022 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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05/27/2022 | SUPPL-9 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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02/16/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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11/26/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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11/26/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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11/26/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; 12.5MG;EQ 10MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 12.5MG;EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 091524 | APOTEX |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 12.5MG;EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078450 | AUROBINDO PHARMA |
TABLET;ORAL; 12.5MG;EQ 20MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 12.5MG;EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 091524 | APOTEX |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 12.5MG;EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 078450 | AUROBINDO PHARMA |
TABLET;ORAL; 25MG;EQ 20MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 25MG;EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 091524 | APOTEX |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE | 25MG;EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 078450 | AUROBINDO PHARMA |