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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 022038


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NDA 022038 describes DIVIGEL, which is a drug marketed by Vertical Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the DIVIGEL profile page.

The generic ingredient in DIVIGEL is estradiol. There are seventy-five drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the estradiol profile page.
Summary for 022038
Tradename:DIVIGEL
Applicant:Vertical Pharms
Ingredient:estradiol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 022038
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 022038
Suppliers and Packaging for NDA: 022038
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIVIGEL estradiol GEL;TRANSDERMAL 022038 NDA Trigen Laboratories, LLC 13811-090 13811-090-32 30 PACKET in 1 CARTON (13811-090-32) / .25 g in 1 PACKET
DIVIGEL estradiol GEL;TRANSDERMAL 022038 NDA Trigen Laboratories, LLC 13811-091 13811-091-32 30 PACKET in 1 CARTON (13811-091-32) / .5 g in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TRANSDERMALStrength0.1%
Approval Date:Jun 4, 2007TE:ABRLD:Yes

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