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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091425
Company: LUPIN LTD

Products on ANDA 091425

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091425

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/18/2013	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-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/09/2017	SUPPL-3	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091425

LEVONORGESTREL AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.02MG;0.1MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AFIRMELLE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB1	206886	AUROBINDO PHARMA
AVIANE-28	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB1	075796	DURAMED PHARMS BARR
FALMINA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB1	090721	NOVAST LABS LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB1	076625	DR REDDYS LABS SA
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB1	212298	HETERO LABS
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB1	091425	LUPIN LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB1	200245	MYLAN LABS LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB1	207065	NAARI PTE LTD
VIENVA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.1MG	TABLET;ORAL-28	Prescription	No	AB1	201088	XIROMED

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