Details for New Drug Application (NDA): 204017

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NDA 204017 describes TWIRLA, which is a drug marketed by Agile 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 TWIRLA profile page.

The generic ingredient in TWIRLA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for 204017

Tradename:	TWIRLA
Applicant:	Agile
Ingredient:	ethinyl estradiol; levonorgestrel
Patents:	3

Pharmacology for NDA: 204017

Mechanism of Action	Estrogen Receptor Agonists
Physiological Effect	Inhibit Ovum Fertilization

Suppliers and Packaging for NDA: 204017

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017	NDA	Agile Therapeutics, Inc.	71671-100	71671-100-01	1 POUCH in 1 CARTON (71671-100-01) / 1 PATCH in 1 POUCH (71671-100-11)
TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017	NDA	Agile Therapeutics, Inc.	71671-100	71671-100-03	3 POUCH in 1 CARTON (71671-100-03) / 1 PATCH in 1 POUCH (71671-100-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SYSTEM;TRANSDERMAL			Strength	0.03MG/24HR;0.12MG/24HR
Approval Date:	Feb 14, 2020	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Aug 26, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Jul 10, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Jul 10, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 204017

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020	⤷ Sign Up	⤷ Sign Up
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020	⤷ Sign Up	⤷ Sign Up
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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