Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 203752
Company: NOVEN

Summary Review

Products on NDA 203752

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MINIVELLE	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	AB3	Yes	No
MINIVELLE	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	AB3	Yes	No
MINIVELLE	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	AB3	Yes	No
MINIVELLE	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	AB3	Yes	Yes
MINIVELLE	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	AB3	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203752

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/2012	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203752lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203752Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203752_minivelle_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203752Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203752s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203752Orig1s022ltr.pdf
10/12/2021	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203752Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203752Orig1s016ltr.pdf
10/19/2021	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203752s012,s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203752Orig1s012,s013ltr.pdf
10/19/2021	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203752s012,s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203752Orig1s012,s013ltr.pdf
11/01/2017	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203752s009lbl.pdf
11/10/2014	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/18/2014	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/23/2014	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203752s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203752Orig1s004ltr.pdf
05/21/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203752

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
02/15/2024	SUPPL-22	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203752s022lbl.pdf
10/19/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203752s012,s013lbl.pdf
10/19/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203752s012,s013lbl.pdf
10/12/2021	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203752Orig1s016lbl.pdf
11/01/2017	SUPPL-9	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203752s009lbl.pdf
09/23/2014	SUPPL-4	Efficacy-New Indication	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203752s004lbl.pdf
10/29/2012	ORIG-1	Approval	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203752lbl.pdf

Therapeutic Equivalents for NDA 203752

MINIVELLE

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.0375MG/24HR
TE Code = AB3

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB3	211396	AMNEAL
ESTRADIOL	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB3	206685	MYLAN TECHNOLOGIES
MINIVELLE	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	Yes	AB3	203752	NOVEN

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.075MG/24HR
TE Code = AB3

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB3	211396	AMNEAL
ESTRADIOL	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB3	206685	MYLAN TECHNOLOGIES
MINIVELLE	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	Yes	AB3	203752	NOVEN

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.05MG/24HR
TE Code = AB3

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB3	211396	AMNEAL
ESTRADIOL	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB3	206685	MYLAN TECHNOLOGIES
MINIVELLE	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	Yes	AB3	203752	NOVEN

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.1MG/24HR
TE Code = AB3

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB3	211396	AMNEAL
ESTRADIOL	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB3	206685	MYLAN TECHNOLOGIES
MINIVELLE	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	Yes	AB3	203752	NOVEN

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.025MG/24HR
TE Code = AB3

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTRADIOL	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB3	211396	AMNEAL
ESTRADIOL	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB3	206685	MYLAN TECHNOLOGIES
MINIVELLE	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	Yes	AB3	203752	NOVEN