Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090719
Company: NOVAST LABS LTD

Products on ANDA 090719

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVONEST	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090719

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/2010	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
04/29/2022	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/16/2022	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/09/2017	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090719

LEVONEST

TABLET;ORAL-28; 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ENPRESSE-28	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET;ORAL-28	Prescription	No	AB	075809	DURAMED PHARMS BARR
LEVONEST	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET;ORAL-28	Prescription	No	AB	090719	NOVAST LABS LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET;ORAL-28	Prescription	No	AB	200248	LUPIN
TRIVORA-28	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG	TABLET;ORAL-28	Prescription	No	AB	074538	DR REDDYS LABS SA