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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022038
Company: VERTICAL PHARMS

Summary Review

Products on NDA 022038

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIVIGEL	ESTRADIOL	0.1%	GEL;TRANSDERMAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022038

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/04/2007	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/2007/022038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022038s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022038s000_divigel_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022038s000_SUMR.pdf

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/2024/022038s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022038Orig1s012ltr.pdf
05/23/2023	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022038s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022038Orig1s010ltr.pdf
12/12/2019	SUPPL-6	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022038s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022038Orig1s005,s006ltr.pdf
12/12/2019	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022038s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022038Orig1s005,s006ltr.pdf
08/17/2018	SUPPL-4	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022038s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022038Orig1s004ltr.pdf
11/01/2017	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022038s003lbl.pdf
05/29/2012	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022038s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022038s002ltr.pdf

Labels for NDA 022038

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/2024/022038s012lbl.pdf
05/23/2023	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022038s010lbl.pdf
12/12/2019	SUPPL-6	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022038s005s006lbl.pdf
12/12/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022038s005s006lbl.pdf
08/17/2018	SUPPL-4	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022038s004lbl.pdf
11/01/2017	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022038s003lbl.pdf
05/29/2012	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022038s002lbl.pdf
06/04/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022038lbl.pdf

Therapeutic Equivalents for NDA 022038

DIVIGEL

GEL;TRANSDERMAL; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIVIGEL	ESTRADIOL	0.1%	GEL;TRANSDERMAL	Prescription	Yes	AB	022038	VERTICAL PHARMS
ESTRADIOL	ESTRADIOL	0.1%	GEL;TRANSDERMAL	Prescription	No	AB	211783	CHEMO RESEARCH SL
ESTRADIOL	ESTRADIOL	0.1%	GEL;TRANSDERMAL	Prescription	No	AB	217610	NOVITIUM PHARMA
ESTRADIOL	ESTRADIOL	0.1%	GEL;TRANSDERMAL	Prescription	No	AB	216524	PADAGIS ISRAEL

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