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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076549
Company: WATSON LABS

Other Important Information from FDA

Products on ANDA 076549

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	Discontinued	None	No	No
RAMIPRIL	RAMIPRIL	10MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076549

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/24/2005	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076549ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/23/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
12/21/2015	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
12/21/2015	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
09/25/2014	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
01/17/2013	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
01/17/2013	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
01/17/2013	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
09/10/2010	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076549

RAMIPRIL

CAPSULE;ORAL; 1.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALTACE	RAMIPRIL	1.25MG	CAPSULE;ORAL	Prescription	Yes	AB	019901	KING PHARMS LLC
RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE;ORAL	Prescription	No	AB	202392	ACCORD HLTHCARE
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	078191	DR REDDYS LABS LTD
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	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
ALTACE	RAMIPRIL	2.5MG	CAPSULE;ORAL	Prescription	Yes	AB	019901	KING PHARMS LLC
RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE;ORAL	Prescription	No	AB	202392	ACCORD HLTHCARE
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	078191	DR REDDYS LABS LTD
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	076549	WATSON LABS
RAMIPRIL	RAMIPRIL	2.5MG	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
ALTACE	RAMIPRIL	10MG	CAPSULE;ORAL	Prescription	Yes	AB	019901	KING PHARMS LLC
RAMIPRIL	RAMIPRIL	10MG	CAPSULE;ORAL	Prescription	No	AB	202392	ACCORD HLTHCARE
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	078191	DR REDDYS LABS LTD
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	076549	WATSON LABS
RAMIPRIL	RAMIPRIL	10MG	CAPSULE;ORAL	Prescription	No	AB	078832	ZYDUS PHARMS USA

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