Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205947
Company: LUPIN LTD

Products on ANDA 205947

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205947

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/2018	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
10/19/2023	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/19/2023	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/12/2020	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 205947

DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM

TABLET;ORAL; 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BEYAZ	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET;ORAL	Prescription	Yes	AB	022532	BAYER HLTHCARE
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET;ORAL	Prescription	No	AB	205947	LUPIN LTD
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	TABLET;ORAL	Prescription	No	AB	203593	WATSON LABS INC