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Generated: September 26, 2017

DrugPatentWatch Database Preview

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-five suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

Summary for NDA: 020475

Tradename:
2
Applicant:
1
Ingredient:
1
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:► SubscribePatent 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:► SubscribePatent 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:► SubscribePatent 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;TOPICAL020475-001Feb 7, 1997► Subscribe► Subscribe
Valeant Intl
RETIN-A MICRO
tretinoin
GEL;TOPICAL020475-002May 10, 2002► Subscribe► Subscribe
Valeant Intl
RETIN-A MICRO
tretinoin
GEL;TOPICAL020475-002May 10, 2002► Subscribe► Subscribe
Valeant Intl
RETIN-A-MICRO
tretinoin
GEL;TOPICAL020475-003Jan 28, 2014► Subscribe► Subscribe
Valeant Intl
RETIN-A MICRO
tretinoin
GEL;TOPICAL020475-001Feb 7, 1997► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Dow
Boehringer Ingelheim
Moodys
Colorcon
Federal Trade Commission
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Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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