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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017579

RETIN-A (TRETINOIN)
0.025%
Marketing Status: Prescription
Active Ingredient: TRETINOIN
Proprietary Name: RETIN-A
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 0.025%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N017579
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: VALEANT INTERNATIONAL BARBADOS SRL
Marketing Status:  Prescription
Patent and Exclusivity Information
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