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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021355
Company: BAYER HLTHCARE

Products on NDA 021355

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ANGELIQ	DROSPIRENONE; ESTRADIOL	0.25MG;0.5MG	TABLET;ORAL	Prescription	None	Yes	No
ANGELIQ	DROSPIRENONE; ESTRADIOL	0.5MG;1MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021355

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2005	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021355lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021355ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021355s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021355s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021355Orig1s012ltr.pdf
10/02/2023	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021355s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021355Orig1s009;s010ltr.pdf
10/02/2023	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021355s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021355Orig1s009;s010ltr.pdf
11/01/2017	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021355s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021355Orig1s008ltr.pdf
06/30/2015	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021355s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021355Orig1s006ltr.pdf
01/26/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/29/2012	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021355s003ltr.pdf
02/29/2012	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021355s002ltr.pdf

Labels for NDA 021355

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021355s012lbl.pdf
10/02/2023	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021355s009s010lbl.pdf
10/02/2023	SUPPL-10	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021355s009s010lbl.pdf
10/02/2023	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021355s009s010lbl.pdf
11/01/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021355s008lbl.pdf
06/30/2015	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021355s006lbl.pdf
02/29/2012	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s003lbl.pdf
02/29/2012	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s002lbl.pdf
09/28/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021355lbl.pdf

Therapeutic Equivalents for NDA 021355

ANGELIQ

TABLET;ORAL; 0.5MG;1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANGELIQ	DROSPIRENONE; ESTRADIOL	0.5MG;1MG	TABLET;ORAL	Prescription	Yes	AB	021355	BAYER HLTHCARE
DROSPIRENONE AND ESTRADIOL	DROSPIRENONE; ESTRADIOL	0.5MG;1MG	TABLET;ORAL	Prescription	No	AB	218031	NOVAST LABS

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