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Details for New Drug Application (NDA): 022057

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NDA 022057 describes ENDOMETRIN, which is a drug marketed by Ferring and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the ENDOMETRIN profile page.

The generic ingredient in ENDOMETRIN is progesterone. There are fifty-one drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the progesterone profile page.

Summary for NDA: 022057

Tradename:
ENDOMETRIN
Applicant:
Ferring
Ingredient:
progesterone
Patents:3
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 022057

Ingredient-typeProgesterone

Suppliers and Packaging for NDA: 022057

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENDOMETRIN
progesterone
INSERT;VAGINAL 022057 NDA Ferring Pharmaceuticals Inc. 55566-6500 55566-6500-3 1 CARTON in 1 CARTON (55566-6500-3) > 21 BLISTER PACK in 1 CARTON (55566-6500-2) > 1 INSERT in 1 BLISTER PACK (55566-6500-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INSERT;VAGINALStrength100MG
Approval Date:Jun 21, 2007TE:RLD:Yes
Patent:7,393,543Patent Expiration:Nov 17, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:ENDOMETRIN IS A PROGESTERONE INDICATED TO SUPPORT EMBRYO IMPLANTATION AND EARLY PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED REPRODUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN
Patent:7,300,664Patent Expiration:Nov 17, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:SUPPORT EMBRYO IMPLANTATION AND EARLY PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED REPORDUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN
Patent:7,320,800Patent Expiration:Nov 17, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:SUPPORT EMBRYO IMPLANTATION AND EARLY PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED REPORDUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN


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