Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021674
Company: BAYER HLTHCARE

• Approved Labeling 10/10/2013

Products on NDA 021674

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MENOSTAR	ESTRADIOL	0.014MG/24HR	SYSTEM;TRANSDERMAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021674

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/08/2004	ORIG-1	Approval	Type 6 - New Indication (no longer used)	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21674_menostar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21674ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021674_s000_MenostarTOC.html

Labels for NDA 021674

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/08/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21674_menostar_lbl.pdf

Therapeutic Equivalents for NDA 021674

MENOSTAR

SYSTEM;TRANSDERMAL; 0.014MG/24HR
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.014MG/24HR	SYSTEM;TRANSDERMAL	Prescription	No	AB	204379	ZYDUS PHARMS
MENOSTAR	ESTRADIOL	0.014MG/24HR	SYSTEM;TRANSDERMAL	Prescription	Yes	AB	021674	BAYER HLTHCARE