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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091346
Company: GLENMARK PHARMS LTD

Products on ANDA 091346

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIORELE	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091346

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/02/2012	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
04/25/2024	SUPPL-16	Labeling-Patient Package Insert		Label is not available on this site.
08/25/2023	SUPPL-14	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/25/2023	SUPPL-13	Labeling-Patient Package Insert		Label is not available on this site.
04/29/2022	SUPPL-11	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/09/2017	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/13/2015	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/28/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091346

VIORELE

TABLET;ORAL-28; 0.15MG,N/A;0.02MG,0.01MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BEKYREE	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	No	AB	202226	LUPIN LTD
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	No	AB	209170	NAARI PTE LTD
DESOGESTREL AND ETHINYL ESTRADIOL	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	No	AB	202296	XIROMED
KARIVA	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	No	AB	075863	BARR
KIMIDESS	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	No	AB	076681	VINTAGE PHARMS
PIMTREA	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	No	AB	091247	NOVAST LABS
SIMLIYA	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	No	AB	206853	AUROBINDO PHARMA
VIORELE	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	No	AB	091346	GLENMARK PHARMS LTD
VOLNEA	DESOGESTREL; ETHINYL ESTRADIOL	0.15MG,N/A;0.02MG,0.01MG	TABLET;ORAL-28	Prescription	No	AB	202689	XIROMED

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