Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201585
Company: LUPIN LTD

Products on ANDA 201585

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BLISOVI FE 1.5/30	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.03MG;1.5MG	TABLET;ORAL-28	Prescription	BX	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201585

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/18/2015	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/09/2023	SUPPL-20	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/09/2023	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
05/02/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
05/02/2019	SUPPL-5	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201585

BLISOVI FE 1.5/30

There are no Therapeutic Equivalents.