Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020475

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RETIN-A MICRO (TRETINOIN)
0.04%
Marketing Status: Prescription

Active Ingredient: TRETINOIN
Proprietary Name: RETIN-A MICRO
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 0.04%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020475
Product Number: 002
Approval Date: May 10, 2002
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

RETIN-A MICRO (TRETINOIN)
0.1%
Marketing Status: Prescription

Active Ingredient: TRETINOIN
Proprietary Name: RETIN-A MICRO
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 0.1%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020475
Product Number: 001
Approval Date: Feb 7, 1997
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

RETIN-A-MICRO (TRETINOIN)
0.06%
Marketing Status: Prescription

Active Ingredient: TRETINOIN
Proprietary Name: RETIN-A-MICRO
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 0.06%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020475
Product Number: 004
Approval Date: Oct 23, 2017
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

RETIN-A-MICRO (TRETINOIN)
0.08%
Marketing Status: Prescription

Active Ingredient: TRETINOIN
Proprietary Name: RETIN-A-MICRO
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 0.08%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020475
Product Number: 003
Approval Date: Jan 28, 2014
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information