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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-two 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 NDA: 050802

Tradename:
ZIANA
Applicant:
Medicis
Ingredient:
clindamycin phosphate; tretinoin
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 050802

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 Medicis Pharmaceutical Corp 99207-300 99207-300-02 12 TUBE in 1 CARTON (99207-300-02) > 2 g in 1 TUBE
ZIANA
clindamycin phosphate; tretinoin
GEL;TOPICAL 050802 NDA Medicis Pharmaceutical Corp 99207-300 99207-300-30 1 TUBE in 1 CARTON (99207-300-30) > 30 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength1.2%;0.025%
Approval Date:Nov 7, 2006TE:ABRLD:Yes
Patent:6,387,383Patent Expiration:Aug 3, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER

Expired Orange Book Patents for NDA: 050802

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicis
ZIANA
clindamycin phosphate; tretinoin
GEL;TOPICAL050802-001Nov 7, 20065,721,275► subscribe
Medicis
ZIANA
clindamycin phosphate; tretinoin
GEL;TOPICAL050802-001Nov 7, 2006RE41134► subscribe
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