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Details for New Drug Application (NDA): 020475

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NDA 020475 describes RETIN-A-MICRO, which is a drug marketed by Valeant Intl and is included in one NDA. It is available from four suppliers. There is one patent protecting this drug. Additional details are available on the RETIN-A-MICRO profile page.

The generic ingredient in RETIN-A-MICRO is tretinoin. There are twenty-four drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

Summary for NDA: 020475

Tradename:
RETIN-A MICRO
Applicant:
Valeant Intl
Ingredient:
tretinoin
Patents:1
Therapeutic Class:Antineoplastics
Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020475

Ingredient-typeRetinoids

Suppliers and Packaging for NDA: 020475

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RETIN-A MICRO
tretinoin
GEL;TOPICAL 020475 NDA Valeant Pharmaceuticals North America LLC 0187-5140 0187-5140-20 1 TUBE in 1 CARTON (0187-5140-20) > 20 g in 1 TUBE
RETIN-A MICRO
tretinoin
GEL;TOPICAL 020475 NDA Valeant Pharmaceuticals North America LLC 0187-5140 0187-5140-45 1 TUBE in 1 CARTON (0187-5140-45) > 45 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.1%
Approval Date:Feb 7, 1997TE:ABRLD:Yes
Patent:5,955,109Patent Expiration:Sep 21, 2016Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE VULGARIS

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.04%
Approval Date:May 10, 2002TE:ABRLD:Yes
Patent:5,955,109Patent Expiration:Sep 21, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE VULGARIS

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.08%
Approval Date:Jan 28, 2014TE:RLD:Yes
Patent:5,955,109Patent Expiration:Sep 21, 2016Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE VULGARIS

Expired Orange Book Patents for NDA: 020475

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl
RETIN-A MICRO
tretinoin
GEL;TOPICAL020475-002May 10, 20024,690,825► subscribe
Valeant Intl
RETIN-A-MICRO
tretinoin
GEL;TOPICAL020475-003Jan 28, 20145,955,109► subscribe
Valeant Intl
RETIN-A MICRO
tretinoin
GEL;TOPICAL020475-001Feb 7, 19975,955,109► subscribe
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