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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091408
Company: LUPIN LTD

Products on ANDA 091408

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091408

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/17/2012	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
02/03/2023	SUPPL-15	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
04/29/2022	SUPPL-14	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/01/2022	SUPPL-13	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/02/2020	SUPPL-10	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
03/02/2020	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
03/02/2020	SUPPL-7	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
08/09/2017	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
01/28/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091408

KURVELO

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALTAVERA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL-28	Prescription	No	AB	079102	XIROMED
AYUNA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL-28	Prescription	No	AB	206866	AUROBINDO PHARMA
KURVELO	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL-28	Prescription	No	AB	091408	LUPIN LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL-28	Prescription	No	AB	207033	NAARI PTE
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL-28	Prescription	No	AB	091663	XIROMED
LEVORA 0.15/30-28	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL-28	Prescription	No	AB	073594	DR REDDYS LABS SA
MARLISSA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL-28	Prescription	No	AB	091452	GLENMARK PHARMS LTD
PORTIA-28	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG;0.15MG	TABLET;ORAL-28	Prescription	No	AB	075866	BARR

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