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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201887
Company: LUPIN LTD

Products on ANDA 201887

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENSKYCE	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201887

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/07/2013	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
04/29/2022	SUPPL-19	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
11/15/2019	SUPPL-15	Labeling-Container/Carton Labels		Label is not available on this site.
05/23/2019	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
05/23/2019	SUPPL-10	Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/23/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/09/2017	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
06/02/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/19/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/01/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201887

ENSKYCE

TABLET;ORAL-28; 0.15MG;0.03MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AVERI	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	218933	AVION PHARMS
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	219761	ANNORA PHARMA
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	075256	DURAMED PHARMS BARR
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	207067	NAARI PTE
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	091234	NOVAST LABS
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	076915	WATSON LABS
ENSKYCE	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	201887	LUPIN LTD
ISIBLOOM	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	202789	XIROMED
KALLIGA	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	207081	AUROBINDO PHARMA

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