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Details for New Drug Application (NDA): 009402

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NDA 009402 describes DELESTROGEN, which is a drug marketed by Par Sterile Products 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 are seventy-five drug master file entries 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:	Par Sterile Products
Ingredient:	estradiol valerate
Patents:	0
Formulation / Manufacturing:	see details

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 Pharmaceutical, Inc.	42023-110	42023-110-01	5 mL in 1 VIAL, MULTI-DOSE (42023-110-01)
DELESTROGEN	estradiol valerate	INJECTABLE;INJECTION	009402	NDA	Par Pharmaceutical, Inc.	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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	40MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AO	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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