Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210233
Company: NAARI PTE

Products on ANDA 210233

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADIOL AND NORETHINDRONE ACETATE	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210233

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210233

ESTRADIOL AND NORETHINDRONE ACETATE

TABLET;ORAL; 1MG;0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACTIVELLA	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	Yes	AB	020907	AMNEAL
ESTRADIOL AND NORETHINDRONE ACETATE	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	No	AB	079193	BARR
ESTRADIOL AND NORETHINDRONE ACETATE	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	No	AB	078324	BRECKENRIDGE PHARM
ESTRADIOL AND NORETHINDRONE ACETATE	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	No	AB	210233	NAARI PTE
ESTRADIOL AND NORETHINDRONE ACETATE	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	No	AB	210612	NOVAST LABS
ESTRADIOL AND NORETHINDRONE ACETATE	ESTRADIOL; NORETHINDRONE ACETATE	1MG;0.5MG	TABLET;ORAL	Prescription	No	AB	207261	XIROMED