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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020375
Company: BAYER HLTHCARE

Products on NDA 20375

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLIMARA	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	AB2	Yes	No
CLIMARA	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	AB2	Yes	Yes
CLIMARA	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	AB2	Yes	No
CLIMARA	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	AB2	Yes	No
CLIMARA	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	AB2	Yes	No
CLIMARA	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	AB2	Yes	No
MENOSTAR	ESTRADIOL	0.014MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	TBD	No

Labels for NDA 020375

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-50	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020375s049s050lbl.pdf
02/15/2024	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020375s049s050lbl.pdf
09/30/2021	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020375s036s037lbl.pdf
09/30/2021	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020375s036s037lbl.pdf
09/16/2021	SUPPL-46	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020375Orig1s045,s046lbl.pdf
09/16/2021	SUPPL-45	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020375Orig1s045,s046lbl.pdf
11/01/2017	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020375s035lbl.pdf
11/01/2017	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020375s034lbl.pdf
10/09/2013	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020375s027lbl.pdf
01/03/2008	SUPPL-26	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020375s026lbl.pdf
12/28/2005	SUPPL-23	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020375s023LBL.pdf
06/22/2005	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020375s022lbl.pdf
01/22/2004	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020375S020lbl.pdf
04/05/2001	SUPPL-16	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20375s16lbl.pdf
04/04/2001	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20375S14lbl.pdf
03/05/1999	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020994_appltr_prntlbl.pdf
03/23/1998	SUPPL-9	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20375s009_Climara_prntlbl.pdf

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