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Generated: September 22, 2017

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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. Two suppliers are listed for this compound. Additional details are available on the estradiol valerate profile page.

Summary for NDA: 009402

Tradename:	1
Applicant:	1
Ingredient:	1
Patents:	0
Therapeutic Class:	Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:	see details

Pharmacology for NDA: 009402

Ingredient-type	Estradiol Congeners
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)

Summary for product number 002

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

Summary 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

Summary 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.