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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211944
Company: HETERO LABS

Products on ANDA 211944

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211944

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/16/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/16/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211944

DROSPIRENONE AND ETHINYL ESTRADIOL

TABLET;ORAL; 3MG;0.02MG
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;0.02MG	TABLET;ORAL	Prescription	No	AB	204296	GLENMARK PHARMS LTD
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	211944	HETERO LABS
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	203291	HLTHCARE
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	202594	MYLAN LABS LTD
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	078833	WATSON LABS
LO-ZUMANDIMINE	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	209632	AUROBINDO PHARMA LTD
LORYNA	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	079221	XIROMED
MELAMISA	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	202016	NOVAST LABS
NIKKI	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	No	AB	201661	LUPIN LTD
YAZ	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.02MG	TABLET;ORAL	Prescription	Yes	AB	021676	BAYER HLTHCARE

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