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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203163
Company: GLENMARK PHARMS LTD

Products on ANDA 203163

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ASHLYNA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.01MG;0.15MG,N/A	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203163

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/23/2015	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
07/31/2023	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/31/2023	SUPPL-3	Labeling-Patient Package Insert		Label is not available on this site.
01/13/2021	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203163

ASHLYNA

TABLET;ORAL; 0.03MG,0.01MG;0.15MG,N/A
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ASHLYNA	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.01MG;0.15MG,N/A	TABLET;ORAL	Prescription	No	AB	203163	GLENMARK PHARMS LTD
DAYSEE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.01MG;0.15MG,N/A	TABLET;ORAL	Prescription	No	AB	091467	LUPIN LTD
JAIMIESS	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.01MG;0.15MG,N/A	TABLET;ORAL	Prescription	No	AB	203770	XIROMED
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.01MG;0.15MG,N/A	TABLET;ORAL	Prescription	No	AB	203872	AMNEAL PHARMS
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.01MG;0.15MG,N/A	TABLET;ORAL	Prescription	No	AB	078834	DR REDDYS LABS SA
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.01MG;0.15MG,N/A	TABLET;ORAL	Prescription	No	AB	200492	MYLAN LABS LTD
SEASONIQUE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.01MG;0.15MG,N/A	TABLET;ORAL	Prescription	Yes	AB	021840	TEVA BRANDED PHARM
SIMPESSE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.03MG,0.01MG;0.15MG,N/A	TABLET;ORAL	Prescription	No	AB	206851	AUROBINDO PHARMA

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