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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090114
Company: XIROMED

Products on ANDA 090114

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SYEDA	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.03MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090114

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/2011	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
09/22/2023	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
04/20/2023	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
04/20/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/20/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
06/13/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/02/2011	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090114

SYEDA

TABLET;ORAL-28; 3MG;0.03MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	090081	DR REDDYS LABS SA
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	204848	GLENMARK PHARMS LTD
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	213034	HETERO LABS
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	201663	LUPIN LTD
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	202131	MYLAN LABS LTD
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	207245	NAARI PTE LTD
SYEDA	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	090114	XIROMED
YAELA	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	202015	NOVAST LABS
YASMIN	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.03MG	TABLET;ORAL-28	Prescription	Yes	AB	021098	BAYER HLTHCARE
ZUMANDIMINE	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.03MG	TABLET;ORAL-28	Prescription	No	AB	209407	AUROBINDO PHARMA LTD

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