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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077900
Company: HIKMA

Other Important Information from FDA

Products on ANDA 077900

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 077900

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/18/2008	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
12/09/2019	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
12/09/2019	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
09/26/2014	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/26/2014	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
09/26/2014	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/26/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/26/2014	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
01/12/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/27/2010	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
10/22/2009	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077900

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; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALTACE	RAMIPRIL	5MG	CAPSULE;ORAL	Prescription	Yes	AB	019901	KING PHARMS LLC
RAMIPRIL	RAMIPRIL	5MG	CAPSULE;ORAL	Prescription	No	AB	202392	ACCORD HLTHCARE
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	078191	DR REDDYS LABS LTD
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	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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