Details for New Drug Application (NDA): 022038

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-nine 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

Pharmacology for NDA: 022038

Mechanism of Action

Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 022038

Estrogens

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:	RX	Dosage:	GEL;TRANSDERMAL			Strength	0.1% (0.25GM/PACKET)
Approval Date:	Jun 4, 2007	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TRANSDERMAL			Strength	0.1% (0.5GM/PACKET)
Approval Date:	Jun 4, 2007	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TRANSDERMAL			Strength	0.1% (1GM/PACKET)
Approval Date:	Jun 4, 2007	TE:	AB	RLD:	Yes

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