An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 091604
Company: AUROBINDO PHARMA LTD

Products on ANDA 091604

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE;ORAL	Prescription	AB	No	No
RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE;ORAL	Prescription	AB	No	No
RAMIPRIL	RAMIPRIL	5MG	CAPSULE;ORAL	Prescription	AB	No	No
RAMIPRIL	RAMIPRIL	10MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091604

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/08/2011	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
10/01/2021	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
04/02/2021	SUPPL-8	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
03/28/2016	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
02/18/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/18/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
02/18/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/18/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091604

RAMIPRIL

CAPSULE;ORAL; 1.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE;ORAL	Prescription	No	AB	091604	AUROBINDO PHARMA LTD
RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE;ORAL	Prescription	No	AB	078745	CHARTWELL MOLECULAR
RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE;ORAL	Prescription	No	AB	079116	COREPHARMA
RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE;ORAL	Prescription	No	AB	077900	HIKMA
RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE;ORAL	Prescription	No	AB	077626	LUPIN
RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE;ORAL	Prescription	No	AB	078191	SENORES PHARMS
RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE;ORAL	Prescription	No	AB	076549	WATSON LABS
RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE;ORAL	Prescription	No	AB	078832	ZYDUS PHARMS USA

CAPSULE;ORAL; 2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE;ORAL	Prescription	No	AB	091604	AUROBINDO PHARMA LTD
RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE;ORAL	Prescription	No	AB	078745	CHARTWELL MOLECULAR
RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE;ORAL	Prescription	No	AB	079116	COREPHARMA
RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE;ORAL	Prescription	No	AB	077900	HIKMA
RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE;ORAL	Prescription	No	AB	077626	LUPIN
RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE;ORAL	Prescription	No	AB	078191	SENORES PHARMS
RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE;ORAL	Prescription	No	AB	076549	WATSON LABS
RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE;ORAL	Prescription	No	AB	078832	ZYDUS PHARMS USA

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RAMIPRIL	RAMIPRIL	5MG	CAPSULE;ORAL	Prescription	No	AB	091604	AUROBINDO PHARMA LTD
RAMIPRIL	RAMIPRIL	5MG	CAPSULE;ORAL	Prescription	No	AB	078745	CHARTWELL MOLECULAR
RAMIPRIL	RAMIPRIL	5MG	CAPSULE;ORAL	Prescription	No	AB	079116	COREPHARMA
RAMIPRIL	RAMIPRIL	5MG	CAPSULE;ORAL	Prescription	No	AB	077900	HIKMA
RAMIPRIL	RAMIPRIL	5MG	CAPSULE;ORAL	Prescription	No	AB	077626	LUPIN
RAMIPRIL	RAMIPRIL	5MG	CAPSULE;ORAL	Prescription	No	AB	078191	SENORES PHARMS
RAMIPRIL	RAMIPRIL	5MG	CAPSULE;ORAL	Prescription	No	AB	078832	ZYDUS PHARMS USA

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RAMIPRIL	RAMIPRIL	10MG	CAPSULE;ORAL	Prescription	No	AB	091604	AUROBINDO PHARMA LTD
RAMIPRIL	RAMIPRIL	10MG	CAPSULE;ORAL	Prescription	No	AB	078745	CHARTWELL MOLECULAR
RAMIPRIL	RAMIPRIL	10MG	CAPSULE;ORAL	Prescription	No	AB	079116	COREPHARMA
RAMIPRIL	RAMIPRIL	10MG	CAPSULE;ORAL	Prescription	No	AB	077900	HIKMA
RAMIPRIL	RAMIPRIL	10MG	CAPSULE;ORAL	Prescription	No	AB	077626	LUPIN
RAMIPRIL	RAMIPRIL	10MG	CAPSULE;ORAL	Prescription	No	AB	078191	SENORES PHARMS
RAMIPRIL	RAMIPRIL	10MG	CAPSULE;ORAL	Prescription	No	AB	076549	WATSON LABS
RAMIPRIL	RAMIPRIL	10MG	CAPSULE;ORAL	Prescription	No	AB	078832	ZYDUS PHARMS USA

Top