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Last Updated: November 22, 2024

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 ActionEstrogen 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:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.05MG/24HR;0.14MG/24HR
Approval Date:Aug 7, 1998TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.05MG/24HR;0.25MG/24HR
Approval Date:Aug 7, 1998TE:RLD:Yes

Expired US Patents for NDA 020870

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 020870-001 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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