Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

• Summary Review

Products on NDA 22038

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIVIGEL	ESTRADIOL	0.1% (0.25GM/PACKET)	GEL;TRANSDERMAL	Prescription	AB	Yes	Yes
DIVIGEL	ESTRADIOL	0.1% (0.5GM/PACKET)	GEL;TRANSDERMAL	Prescription	AB	Yes	Yes
DIVIGEL	ESTRADIOL	0.1% (1GM/PACKET)	GEL;TRANSDERMAL	Prescription	AB	Yes	Yes
DIVIGEL	ESTRADIOL	0.1% (0.75GM/PACKET)	GEL;TRANSDERMAL	Prescription	AB	Yes	Yes
DIVIGEL	ESTRADIOL	0.1% (1.25GM/PACKET)	GEL;TRANSDERMAL	Prescription	AB	Yes	Yes

Labels for NDA 022038

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/12/2026	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022038s017lbl.pdf
04/29/2025	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022038Orig1s014lbl.pdf
04/29/2025	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022038Orig1s014lbl.pdf
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