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Details for New Drug Application (NDA): 020600

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NDA 020600 describes TAZORAC, which is a drug marketed by Allergan and is included in two NDAs. It is available from two suppliers. Additional details are available on the TAZORAC profile page.

The generic ingredient in TAZORAC is tazarotene. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tazarotene profile page.

Summary for NDA: 020600

Tradename:
TAZORAC
Applicant:
Allergan
Ingredient:
tazarotene
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020600

Ingredient-typeRetinoids

Suppliers and Packaging for NDA: 020600

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAZORAC
tazarotene
GEL;TOPICAL 020600 NDA Allergan, Inc. 0023-0042 0023-0042-03 1 TUBE in 1 CARTON (0023-0042-03) > 30 g in 1 TUBE
TAZORAC
tazarotene
GEL;TOPICAL 020600 NDA Allergan, Inc. 0023-0042 0023-0042-10 1 TUBE in 1 CARTON (0023-0042-10) > 100 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.05%
Approval Date:Jun 13, 1997TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.1%
Approval Date:Jun 13, 1997TE:RLD:Yes

Expired Orange Book Patents for NDA: 020600

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan
TAZORAC
tazarotene
GEL;TOPICAL020600-001Jun 13, 19975,089,509► subscribe
Allergan
TAZORAC
tazarotene
GEL;TOPICAL020600-002Jun 13, 19975,914,334► subscribe
Allergan
TAZORAC
tazarotene
GEL;TOPICAL020600-002Jun 13, 19975,089,509► subscribe
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