Details for New Drug Application (NDA): 009402

NDA 009402 describes DELESTROGEN, which is a drug marketed by Ph Health and is included in one NDA. It is available from one supplier. Additional details are available on the DELESTROGEN profile page.

The generic ingredient in DELESTROGEN is estradiol valerate. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the estradiol valerate profile page.

Summary for 009402

Tradename:	DELESTROGEN
Applicant:	Ph Health
Ingredient:	estradiol valerate
Patents:	0

Pharmacology for NDA: 009402

Mechanism of Action

Estrogen Receptor Agonists

Suppliers and Packaging for NDA: 009402

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DELESTROGEN	estradiol valerate	INJECTABLE;INJECTION	009402	NDA	Par Health USA, LLC	42023-110	42023-110-01	5 mL in 1 VIAL, MULTI-DOSE (42023-110-01)
DELESTROGEN	estradiol valerate	INJECTABLE;INJECTION	009402	NDA	Par Health USA, LLC	42023-111	42023-111-01	5 mL in 1 VIAL, MULTI-DOSE (42023-111-01)

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AO	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AO	RLD:	Yes

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