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Last Updated: September 29, 2020

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Details for New Drug Application (NDA): 050802

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NDA 050802 describes ZIANA, which is a drug marketed by Medicis and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ZIANA profile page.

The generic ingredient in ZIANA is clindamycin phosphate; tretinoin. There are fifty-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.
Summary for 050802
Tradename:ZIANA
Applicant:Medicis
Ingredient:clindamycin phosphate; tretinoin
Patents:1
Suppliers and Packaging for NDA: 050802
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-300 68682-300-30 1 TUBE in 1 CARTON (68682-300-30) > 30 g in 1 TUBE
ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-300 68682-300-60 1 TUBE in 1 CARTON (68682-300-60) > 60 g in 1 TUBE
Paragraph IV (Patent) Challenges for 050802
Tradename Dosage Ingredient NDA Submissiondate
ZIANA GEL;TOPICAL clindamycin phosphate; tretinoin 050802 2010-12-17

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength1.2%;0.025%
Approval Date:Nov 7, 2006TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Aug 3, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER

Expired US Patents for NDA 050802

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicis ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802-001 Nov 7, 2006   Start Trial   Start Trial
Medicis ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802-001 Nov 7, 2006   Start Trial   Start Trial
Medicis ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802-001 Nov 7, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Johnson and Johnson
Baxter
Dow
AstraZeneca

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