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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070464
Company: NUVO PHARM

Products on ANDA 070464

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIAZEPAM	DIAZEPAM	10MG	TABLET;ORAL	Prescription	None	No	No
DIAZEPAM	DIAZEPAM	2MG	TABLET;ORAL	Prescription	AB	No	No
DIAZEPAM	DIAZEPAM	5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070464

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/25/1986	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
11/22/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/16/1993	SUPPL-7	Labeling		Label is not available on this site.
06/30/1988	SUPPL-6	Labeling		Label is not available on this site.
04/12/1988	SUPPL-5	Labeling		Label is not available on this site.
07/21/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/21/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 070464

DIAZEPAM

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIAZEPAM	DIAZEPAM	10MG	TABLET;ORAL	Prescription	No	AB	217843	AUROBINDO PHARMA LTD
DIAZEPAM	DIAZEPAM	10MG	TABLET;ORAL	Prescription	No	AB	071136	DR REDDYS LABS SA
DIAZEPAM	DIAZEPAM	10MG	TABLET;ORAL	Prescription	No	AB	071322	IVAX SUB TEVA PHARMS
DIAZEPAM	DIAZEPAM	10MG	TABLET;ORAL	Prescription	No	AB	070325	MYLAN
DIAZEPAM	DIAZEPAM	10MG	TABLET;ORAL	Prescription	No	AB	070464	NUVO PHARM
VALIUM	DIAZEPAM	10MG	TABLET;ORAL	Prescription	Yes	AB	013263	WAYLIS THERAP

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIAZEPAM	DIAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	217843	AUROBINDO PHARMA LTD
DIAZEPAM	DIAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	071134	DR REDDYS LABS SA
DIAZEPAM	DIAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	071307	IVAX SUB TEVA PHARMS
DIAZEPAM	DIAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	070325	MYLAN
DIAZEPAM	DIAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	070464	NUVO PHARM
VALIUM	DIAZEPAM	2MG	TABLET;ORAL	Prescription	Yes	AB	013263	WAYLIS THERAP

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIAZEPAM	DIAZEPAM	5MG	TABLET;ORAL	Prescription	No	AB	217843	AUROBINDO PHARMA LTD
DIAZEPAM	DIAZEPAM	5MG	TABLET;ORAL	Prescription	No	AB	071135	DR REDDYS LABS SA
DIAZEPAM	DIAZEPAM	5MG	TABLET;ORAL	Prescription	No	AB	071321	IVAX SUB TEVA PHARMS
DIAZEPAM	DIAZEPAM	5MG	TABLET;ORAL	Prescription	No	AB	070325	MYLAN
DIAZEPAM	DIAZEPAM	5MG	TABLET;ORAL	Prescription	No	AB	070464	NUVO PHARM
VALIUM	DIAZEPAM	5MG	TABLET;ORAL	Prescription	Yes	AB	013263	WAYLIS THERAP

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