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Generated: May 25, 2017

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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 two suppliers. There are two patents 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-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.

Summary for NDA: 021813

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 021813

Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists

Suppliers and Packaging for NDA: 021813

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEL, METERED;TRANSDERMAL 021813 NDA MEDA Pharmaceuticals 0037-4801 0037-4801-35 1 BOTTLE, PUMP in 1 CARTON (0037-4801-35) > 35 g in 1 BOTTLE, PUMP
GEL, METERED;TRANSDERMAL 021813 NDA MEDA Pharmaceuticals 0037-4802 0037-4802-35 1 BOTTLE, PUMP in 1 CARTON (0037-4802-35) > 35 g in 1 BOTTLE, PUMP

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;TRANSDERMALStrength0.06% (0.87GM/ACTIVATION)
Approval Date:Dec 15, 2006TE:RLD:Yes
Patent:7,198,801Patent Expiration:Jun 25, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:7,470,433Patent Expiration:Aug 3, 2021Product Flag?YSubstance Flag?Delist Request?

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