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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021258
Company: BAYER HLTHCARE

Products on NDA 021258

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLIMARA PRO	ESTRADIOL; LEVONORGESTREL	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021258

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2003	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021258lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21258ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021258s000_ClimaraTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021258s015lbl.pdf
10/07/2021	SUPPL-13	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021258Orig1s013ltr.pdf
11/15/2021	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021258s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021258orig1s012ltr.pdf
11/01/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021258s011lbl.pdf
03/08/2016	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/09/2013	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021258s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021258Orig1s006ltr.pdf
06/22/2005	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021258s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021258s003ltr.pdf

Labels for NDA 021258

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021258s015lbl.pdf
11/15/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021258s012lbl.pdf
11/01/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021258s011lbl.pdf
10/09/2013	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021258s006lbl.pdf
06/22/2005	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021258s003lbl.pdf
11/21/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021258lbl.pdf

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