Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091105
Company: NOVAST LABS LTD

Products on ANDA 091105

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELINEST	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091105

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/2012	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
08/09/2017	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091105

ELINEST

TABLET;ORAL-28; 0.03MG;0.3MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CRYSELLE	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	No	AB	075840	DURAMED PHARMS BARR
ELINEST	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	No	AB	091105	NOVAST LABS LTD
LOW-OGESTREL-28	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	No	AB	075288	DR REDDYS LABS SA
TURQOZ	ETHINYL ESTRADIOL; NORGESTREL	0.03MG;0.3MG	TABLET;ORAL-28	Prescription	No	AB	202980	LUPIN LTD