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

Antineoplastic Agents
Keratolytic Agents

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:	RX	Dosage:	GEL;TOPICAL			Strength	0.1%
Approval Date:	Feb 7, 1997	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	0.04%
Approval Date:	May 10, 2002	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	0.08%
Approval Date:	Jan 28, 2014	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020475

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

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