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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078786
Company: MLV

Products on ANDA 078786

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	AB	No	No
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	AB	No	No
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	AB	No	No
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078786

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2009	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
10/09/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078786

CARVEDILOL

TABLET;ORAL; 3.125MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	078332	AUROBINDO PHARMA
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	077474	CHARTWELL MOLECULAR
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	078251	GLENMARK PHARMS LTD
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	078786	MLV
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	078384	REGCON HOLDINGS
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	076649	RISING
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	078165	RUBICON RESEARCH
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	078227	SANDOZ
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	076373	TEVA
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	077614	ZYDUS PHARMS USA INC
COREG	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	Yes	AB	020297	WAYLIS THERAP

TABLET;ORAL; 6.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	078332	AUROBINDO PHARMA
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	077474	CHARTWELL MOLECULAR
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	078251	GLENMARK PHARMS LTD
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	078786	MLV
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	078384	REGCON HOLDINGS
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	076649	RISING
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	078165	RUBICON RESEARCH
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	078227	SANDOZ
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	076373	TEVA
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	077614	ZYDUS PHARMS USA INC
COREG	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	Yes	AB	020297	WAYLIS THERAP

TABLET;ORAL; 12.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	078332	AUROBINDO PHARMA
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	077474	CHARTWELL MOLECULAR
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	078251	GLENMARK PHARMS LTD
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	078786	MLV
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	078384	REGCON HOLDINGS
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	076649	RISING
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	078165	RUBICON RESEARCH
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	078227	SANDOZ
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	076373	TEVA
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	077614	ZYDUS PHARMS USA INC
COREG	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	Yes	AB	020297	WAYLIS THERAP

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	078332	AUROBINDO PHARMA
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	077474	CHARTWELL MOLECULAR
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	078251	GLENMARK PHARMS LTD
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	078786	MLV
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	078384	REGCON HOLDINGS
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	076649	RISING
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	078165	RUBICON RESEARCH
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	078227	SANDOZ
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	076373	TEVA
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	077614	ZYDUS PHARMS USA INC
COREG	CARVEDILOL	25MG	TABLET;ORAL	Prescription	Yes	AB	020297	WAYLIS THERAP

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