Details for New Drug Application (NDA): 021813

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NDA 021813 describes ELESTRIN, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ELESTRIN profile page.

The generic ingredient in ELESTRIN is estradiol. There are seventy-five drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the estradiol profile page.

Summary for 021813

Tradename:	ELESTRIN
Applicant:	Mylan Speciality Lp
Ingredient:	estradiol
Patents:	1
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021813

Mechanism of Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 021813

Estrogens

Suppliers and Packaging for NDA: 021813

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813	NDA	Meda Pharmaceuticals	0037-4801	0037-4801-70	2 BOTTLE, PUMP in 1 CARTON (0037-4801-70) / 35 g in 1 BOTTLE, PUMP (0037-4801-35)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL, METERED;TRANSDERMAL			Strength	0.06% (0.87GM/ACTIVATION)
Approval Date:	Dec 15, 2006	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Jun 25, 2022	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021813

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006	⤷ Try a Trial	⤷ Try a Trial
Mylan Speciality Lp	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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