An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 091398
Company: LUPIN LTD

Products on ANDA 091398

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BLISOVI 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091398

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2015	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-20	Labeling-Package Insert		Label is not available on this site.
11/15/2019	SUPPL-14	Labeling-Container/Carton Labels		Label is not available on this site.
05/01/2019	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
05/01/2019	SUPPL-5	Labeling, Labeling-Package Insert		Label is not available on this site.
05/01/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091398

BLISOVI 24 FE

TABLET;ORAL; 0.02MG;1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AUROVELA 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	207504	AUROBINDO PHARMA
BLISOVI 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	091398	LUPIN LTD
FINZALA	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	210087	TEVA PHARMS USA INC
GILDESS 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	090293	VINTAGE PHARMS
HAILEY 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	204847	GLENMARK PHARMS LTD
LARIN 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	202994	NOVAST LABS
MIBELAS 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	206287	LUPIN
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	090938	BARR LABS INC
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	210369	GLENMARK PHARMS LTD
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	209609	XIROMED
OSHIH	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG	TABLET;ORAL	Prescription	No	AB	216558	AUROBINDO PHARMA

Top