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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021098
Company: BAYER HLTHCARE

Other Important Information from FDA

Products on NDA 021098

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
YASMIN	DROSPIRENONE; ETHINYL ESTRADIOL	3MG;0.03MG	TABLET;ORAL-28	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021098

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/2001	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21098lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-098_Yasmin_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-098_Yasmin.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021098s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021098Orig1s030ltr.pdf
05/19/2023	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021098s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021098Orig1s029ltr.pdf
08/09/2017	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021098s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021098Orig1s028ltr.pdf
03/08/2016	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
09/30/2014	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
11/26/2014	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
06/01/2015	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021098s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf
04/10/2012	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,022532s004,022574s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021098Orig1s022.pdf
01/31/2013	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
02/13/2012	SUPPL-19	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s019ltr.pdf
04/07/2010	SUPPL-17	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021098s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021098s017ltr.pdf
08/08/2002	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/09/2003	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021098s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21098se8-005ltr.pdf
12/12/2001	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
11/30/2001	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/30/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/26/2001	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 021098

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/19/2023	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021098s029lbl.pdf
04/29/2022	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021098s030lbl.pdf
08/09/2017	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021098s028lbl.pdf
06/01/2015	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021098s023lbl.pdf
04/10/2012	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s022lbl.pdf
02/13/2012	SUPPL-19	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s019lbl.pdf
04/07/2010	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021098s017lbl.pdf
05/09/2003	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021098s005lbl.pdf
05/11/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21098lbl.pdf

Therapeutic Equivalents for NDA 021098

YASMIN

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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