Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205948
Company: LUPIN LTD

Products on ANDA 205948

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TYDEMY	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205948

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/12/2017	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
09/07/2023	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/07/2023	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205948

TYDEMY

TABLET;ORAL; 3MG,N/A;0.03MG,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
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	TABLET;ORAL	Prescription	No	AB	203594	WATSON LABS INC
SAFYRAL	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	TABLET;ORAL	Prescription	Yes	AB	022574	BAYER HLTHCARE
TYDEMY	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	TABLET;ORAL	Prescription	No	AB	205948	LUPIN LTD