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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 020475


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NDA 020475 describes RETIN-A-MICRO, which is a drug marketed by Bausch and is included in one NDA. It is available from three suppliers. Additional details are available on the RETIN-A-MICRO profile page.

The generic ingredient in RETIN-A-MICRO is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
Summary for 020475
Tradename:RETIN-A-MICRO
Applicant:Bausch
Ingredient:tretinoin
Patents:0
Pharmacology for NDA: 020475
Medical Subject Heading (MeSH) Categories for 020475
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 Bausch Health US 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 Bausch Health US LLC 0187-5140 0187-5140-45 1 TUBE in 1 CARTON (0187-5140-45) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.1%
Approval Date:Feb 7, 1997TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.04%
Approval Date:May 10, 2002TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.08%
Approval Date:Jan 28, 2014TE:ABRLD:Yes

Expired US Patents for NDA 020475

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch RETIN-A-MICRO tretinoin GEL;TOPICAL 020475-003 Jan 28, 2014 ⤷  Subscribe ⤷  Subscribe
Bausch RETIN-A MICRO tretinoin GEL;TOPICAL 020475-002 May 10, 2002 ⤷  Subscribe ⤷  Subscribe
Bausch RETIN-A MICRO tretinoin GEL;TOPICAL 020475-001 Feb 7, 1997 ⤷  Subscribe ⤷  Subscribe
Bausch RETIN-A MICRO tretinoin GEL;TOPICAL 020475-001 Feb 7, 1997 ⤷  Subscribe ⤷  Subscribe
Bausch RETIN-A MICRO tretinoin GEL;TOPICAL 020475-002 May 10, 2002 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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