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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079070
Company: AUROBINDO PHARMA

Products on ANDA 079070

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PERINDOPRIL ERBUMINE	PERINDOPRIL ERBUMINE	2MG	TABLET;ORAL	Prescription	AB	No	No
PERINDOPRIL ERBUMINE	PERINDOPRIL ERBUMINE	4MG	TABLET;ORAL	Prescription	AB	No	No
PERINDOPRIL ERBUMINE	PERINDOPRIL ERBUMINE	8MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079070

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/10/2009	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079070s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/10/2024	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
05/20/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
05/20/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
10/17/2011	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
07/21/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 079070

PERINDOPRIL ERBUMINE

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PERINDOPRIL ERBUMINE	PERINDOPRIL ERBUMINE	2MG	TABLET;ORAL	Prescription	No	AB	079070	AUROBINDO PHARMA

TABLET;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PERINDOPRIL ERBUMINE	PERINDOPRIL ERBUMINE	4MG	TABLET;ORAL	Prescription	No	AB	079070	AUROBINDO PHARMA

TABLET;ORAL; 8MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PERINDOPRIL ERBUMINE	PERINDOPRIL ERBUMINE	8MG	TABLET;ORAL	Prescription	No	AB	079070	AUROBINDO PHARMA

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