Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201893
Company: AUROBINDO PHARMA

Products on ANDA 201893

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NADOLOL	NADOLOL	40MG	TABLET;ORAL	Prescription	AB	No	No
NADOLOL	NADOLOL	80MG	TABLET;ORAL	Prescription	AB	No	No
NADOLOL	NADOLOL	20MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201893

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/16/2015	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201893Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/01/2024	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
06/07/2022	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/01/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201893

NADOLOL

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CORGARD	NADOLOL	40MG	TABLET;ORAL	Prescription	Yes	AB	018063	USWM
NADOLOL	NADOLOL	40MG	TABLET;ORAL	Prescription	No	AB	211763	ALEMBIC
NADOLOL	NADOLOL	40MG	TABLET;ORAL	Prescription	No	AB	208832	AMNEAL PHARMS CO
NADOLOL	NADOLOL	40MG	TABLET;ORAL	Prescription	No	AB	201893	AUROBINDO PHARMA
NADOLOL	NADOLOL	40MG	TABLET;ORAL	Prescription	No	AB	210955	BEXIMCO PHARMS USA
NADOLOL	NADOLOL	40MG	TABLET;ORAL	Prescription	No	AB	209309	CHARTWELL RX
NADOLOL	NADOLOL	40MG	TABLET;ORAL	Prescription	No	AB	203455	INVAGEN PHARMS
NADOLOL	NADOLOL	40MG	TABLET;ORAL	Prescription	No	AB	074172	RISING
NADOLOL	NADOLOL	40MG	TABLET;ORAL	Prescription	No	AB	212856	RK PHARMA
NADOLOL	NADOLOL	40MG	TABLET;ORAL	Prescription	No	AB	074501	SANDOZ
NADOLOL	NADOLOL	40MG	TABLET;ORAL	Prescription	No	AB	207761	ZYDUS PHARMS

TABLET;ORAL; 80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CORGARD	NADOLOL	80MG	TABLET;ORAL	Prescription	Yes	AB	018063	USWM
NADOLOL	NADOLOL	80MG	TABLET;ORAL	Prescription	No	AB	211763	ALEMBIC
NADOLOL	NADOLOL	80MG	TABLET;ORAL	Prescription	No	AB	208832	AMNEAL PHARMS CO
NADOLOL	NADOLOL	80MG	TABLET;ORAL	Prescription	No	AB	201893	AUROBINDO PHARMA
NADOLOL	NADOLOL	80MG	TABLET;ORAL	Prescription	No	AB	210955	BEXIMCO PHARMS USA
NADOLOL	NADOLOL	80MG	TABLET;ORAL	Prescription	No	AB	209309	CHARTWELL RX
NADOLOL	NADOLOL	80MG	TABLET;ORAL	Prescription	No	AB	203455	INVAGEN PHARMS
NADOLOL	NADOLOL	80MG	TABLET;ORAL	Prescription	No	AB	074172	RISING
NADOLOL	NADOLOL	80MG	TABLET;ORAL	Prescription	No	AB	212856	RK PHARMA
NADOLOL	NADOLOL	80MG	TABLET;ORAL	Prescription	No	AB	074501	SANDOZ
NADOLOL	NADOLOL	80MG	TABLET;ORAL	Prescription	No	AB	207761	ZYDUS PHARMS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CORGARD	NADOLOL	20MG	TABLET;ORAL	Prescription	Yes	AB	018063	USWM
NADOLOL	NADOLOL	20MG	TABLET;ORAL	Prescription	No	AB	211763	ALEMBIC
NADOLOL	NADOLOL	20MG	TABLET;ORAL	Prescription	No	AB	208832	AMNEAL PHARMS CO
NADOLOL	NADOLOL	20MG	TABLET;ORAL	Prescription	No	AB	201893	AUROBINDO PHARMA
NADOLOL	NADOLOL	20MG	TABLET;ORAL	Prescription	No	AB	210955	BEXIMCO PHARMS USA
NADOLOL	NADOLOL	20MG	TABLET;ORAL	Prescription	No	AB	209309	CHARTWELL RX
NADOLOL	NADOLOL	20MG	TABLET;ORAL	Prescription	No	AB	203455	INVAGEN PHARMS
NADOLOL	NADOLOL	20MG	TABLET;ORAL	Prescription	No	AB	074172	RISING
NADOLOL	NADOLOL	20MG	TABLET;ORAL	Prescription	No	AB	212856	RK PHARMA
NADOLOL	NADOLOL	20MG	TABLET;ORAL	Prescription	No	AB	074501	SANDOZ
NADOLOL	NADOLOL	20MG	TABLET;ORAL	Prescription	No	AB	207761	ZYDUS PHARMS