Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074172
Company: RISING

Products on ANDA 074172

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074172

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/1993	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
08/23/2024	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
06/25/2015	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
06/25/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
05/10/2010	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
08/16/2000	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
02/05/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074172

NADOLOL

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
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

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
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
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