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BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE از شرکت SANDOZ

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اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
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BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE از شرکت SANDOZ

Abbreviated New Drug Application (ANDA): 076631

Company: SANDOZ

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET;ORAL Prescription

None

No No
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET;ORAL Prescription

AB

No No
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET;ORAL Prescription

AB

No No
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;25MG 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
02/11/2004 ORIG-1 Approval

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76631ltr.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/03/2020 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

11/03/2020 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

08/16/2018 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

03/24/2016 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

06/30/2015 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

09/23/2014 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

09/23/2014 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

08/02/2011 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

07/28/2011 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

03/17/2010 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

12/28/2009 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

08/31/2009 SUPPL-9 Labeling

Label is not available on this site.

09/25/2007 SUPPL-7 Labeling

Label is not available on this site.

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 10MG;12.5MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET;ORAL Prescription No AB 076631 SANDOZ
LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10MG;12.5MG TABLET;ORAL Prescription Yes AB 020033 VALIDUS PHARMS

TABLET;ORAL; 20MG;12.5MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET;ORAL Prescription No AB 076631 SANDOZ
LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;12.5MG TABLET;ORAL Prescription Yes AB 020033 VALIDUS PHARMS

TABLET;ORAL; 20MG;25MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;25MG TABLET;ORAL Prescription No AB 076631 SANDOZ
LOTENSIN HCT BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20MG;25MG TABLET;ORAL Prescription Yes AB 020033 VALIDUS PHARMS
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