Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202791
Company: GLENMARK PHARMS LTD

Products on ANDA 202791

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.09MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202791

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/09/2015	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-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/18/2022	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/09/2017	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
06/16/2016	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202791

LEVONORGESTREL AND ETHINYL ESTRADIOL

TABLET;ORAL; 0.02MG;0.09MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOLISHALE	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.09MG	TABLET;ORAL	Prescription	No	AB	091692	NOVAST LABS
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.09MG	TABLET;ORAL	Prescription	No	AB	202791	GLENMARK PHARMS LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG;0.09MG	TABLET;ORAL	Prescription	No	AB	079218	WATSON LABS