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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022574
Company: BAYER HLTHCARE

Other Important Information from FDA

Summary Review

Products on NDA 022574

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SAFYRAL	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	3MG,N/A;0.03MG,N/A;0.451MG,0.451MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022574

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/2010	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022574s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022574s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022574_safyral_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022574Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022574s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022574Orig1s011ltr.pdf
05/19/2023	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022574s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022574Orig1s010ltr.pdf
08/09/2017	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022574s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022574Orig1s009ltr.pdf
06/01/2015	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022574s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf
04/10/2012	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022574s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,022532s004,022574s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022574Orig1s004.pdf
02/13/2012	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022574s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022574s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022574Orig1s001.pdf

Labels for NDA 022574

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/19/2023	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022574s010lbl.pdf
04/29/2022	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022574s011lbl.pdf
08/09/2017	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022574s009lbl.pdf
06/01/2015	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022574s006lbl.pdf
04/10/2012	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022574s004lbl.pdf
02/13/2012	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022574s001lbl.pdf
12/16/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022574s000lbl.pdf

Therapeutic Equivalents for NDA 022574

SAFYRAL

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

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