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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077614
Company: ZYDUS PHARMS USA INC

Products on ANDA 077614

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077614

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/05/2007	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077614s000_ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/03/2020	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
03/25/2016	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/19/2014	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
09/19/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/18/2008	SUPPL-3	Labeling		Label is not available on this site.
10/25/2007	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077614

CARVEDILOL

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	078384	BEXIMCO USA
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	077474	CHARTWELL MOLECULAR
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	076649	DR REDDYS LABS LTD
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	078251	GLENMARK PHARMS LTD
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	078217	LUPIN
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	077316	MYLAN
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	078165	RUBICON
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	078227	SANDOZ
CARVEDILOL	CARVEDILOL	6.25MG	TABLET;ORAL	Prescription	No	AB	077780	TARO
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	WOODWARD

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	078384	BEXIMCO USA
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	077474	CHARTWELL MOLECULAR
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	076649	DR REDDYS LABS LTD
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	078251	GLENMARK PHARMS LTD
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	078217	LUPIN
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	077316	MYLAN
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	078165	RUBICON
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	078227	SANDOZ
CARVEDILOL	CARVEDILOL	12.5MG	TABLET;ORAL	Prescription	No	AB	077780	TARO
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	WOODWARD

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	078384	BEXIMCO USA
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	077474	CHARTWELL MOLECULAR
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	076649	DR REDDYS LABS LTD
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	078251	GLENMARK PHARMS LTD
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	078217	LUPIN
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	077316	MYLAN
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	078165	RUBICON
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	078227	SANDOZ
CARVEDILOL	CARVEDILOL	25MG	TABLET;ORAL	Prescription	No	AB	077780	TARO
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	WOODWARD

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	078384	BEXIMCO USA
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	077474	CHARTWELL MOLECULAR
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	076649	DR REDDYS LABS LTD
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	078251	GLENMARK PHARMS LTD
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	078217	LUPIN
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	077316	MYLAN
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	078165	RUBICON
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	078227	SANDOZ
CARVEDILOL	CARVEDILOL	3.125MG	TABLET;ORAL	Prescription	No	AB	077780	TARO
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	WOODWARD

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