Details for New Drug Application (NDA): 020870

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NDA 020870 describes COMBIPATCH, which is a drug marketed by Noven Pharms Inc and is included in one NDA. It is available from one supplier. Additional details are available on the COMBIPATCH profile page.

The generic ingredient in COMBIPATCH is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.

Summary for 020870

Tradename:	COMBIPATCH
Applicant:	Noven Pharms Inc
Ingredient:	estradiol; norethindrone acetate
Patents:	0

Pharmacology for NDA: 020870

Mechanism of Action	Estrogen Receptor Agonists

Suppliers and Packaging for NDA: 020870

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870	NDA	Noven Therapeutics, LLC	68968-0514	68968-0514-8	8 POUCH in 1 CARTON (68968-0514-8) / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCH
COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870	NDA	Noven Therapeutics, LLC	68968-0525	68968-0525-8	8 POUCH in 1 CARTON (68968-0525-8) / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	0.05MG/24HR;0.14MG/24HR
Approval Date:	Aug 7, 1998	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	0.05MG/24HR;0.25MG/24HR
Approval Date:	Aug 7, 1998	TE:		RLD:	Yes

Expired US Patents for NDA 020870

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-001	Aug 7, 1998	⤷ Sign Up	⤷ Sign Up
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-002	Aug 7, 1998	⤷ Sign Up	⤷ Sign Up
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-001	Aug 7, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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